Who else makes this device?

Name: AutoDELFIA Sample processor
Brand: AutoDELFIA Sample processor

AutoDELFIA Sample Processor · Fluorometer, for Clinical Use → Clinical Chemistry

5manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

3recalls on this code

Who Else Makes It

Concentrated in Beijing (1), Zhejiang (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code KHO
Manufacturer	City	Province	Registered as	Device types
W.h.p.m. Bioresearch & Technology Co., Ltd.	Beijing	Beijing	Manufacturer	37
Vivachek Biotech (Hangzhou) Co., Ltd.	Hangzhou, Zhuji	Zhejiang	Contract manufacturer	21
Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	Nantong	Jiangsu	Manufacturer	11
Yantai Addcare Bio-Tech Co., Ltd.	Yantai	Shandong	Contract manufacturer	8
Guangzhou Labsim Biotech Co., Ltd.	Guangzhou	Guangdong	Manufacturer	3

Record

Regulatory record for AutoDELFIA Sample processor
Listed by	Wallac OY, Finland
FDA product code	KHO
Device type	Fluorometer, For Clinical Use
Device class	Class 1
Regulation	21 CFR 862.2560
Establishment	Complaint-file establishment, Manufacturer, Exporter
Record published	2016-07-01
Record revised	2022-09-16 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for AutoDELFIA Sample processor
Catalogue number	Size	Status
1297-0110		In distribution
1297-014		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sofia	Quidel Corp.	4
Vitros	Ortho-Clinical Diagnostics, Inc.	3
AutoDELFIA Plate processor	Wallac OY	2
Victor EnLite	Wallac OY	2
AutoDELFIA Automatic Immunoassay System	Wallac OY	2
Fluorometer, For Clinical Use	Guangzhou Labsim Biotech Co., Ltd.	2
Macro & Micro-Test Fluorescence Immunoassay Analyzer	Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	2
Asfa® Scanner	MBD Co., Ltd.	2
VICTOR2 D	Wallac OY	2
Seeker™	Baebies Inc.	2
Frend System	Nanoentek Inc	2
Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer Ryan	Carolina Liquid Chemistries	1

Showing 12 of 34. All products under Fluorometer, For Clinical Use

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K935047	1994-05-23

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2017-01-05	Class II	Component change control	The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corros	24 instruments and 3 spare disk remover modules	2017-08-24
2017-01-05	Class II	Component change control	The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corros	24 instruments and 3 spare disk remover modules	2017-08-24
2012-01-09	Not classified	Nonconforming Material/Component	GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs for a normal sample.	10 units	2013-03-06

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

AutoDELFIA Sample Processor