Who else makes this device?

Name: 19tray Sorter
Brand: 19tray Sorter

Clinical Chemistry › Laboratory InstrumentsFluorometer, For Clinical Use

19tray Sorter

19tray Sorter: 1 catalogue number listed by Tosoh Corp., Japan, under Fluorometer, For Clinical Use. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product 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 19tray Sorter
Listed by	Tosoh Corp., Japan
FDA product code	KHO
Device type	Fluorometer, For Clinical Use
Device class	Class 1
Regulation	21 CFR 862.2560
Establishment	Exporter
Premarket notification	Exempt
Record published	2019-09-02
Record revised	2024-04-01 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number
Storage	Special storage condition: Keep dry and store indoor

Catalogue Numbers

Catalogue numbers for 19tray Sorter
Catalogue number	Size	Status
N/A		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
AutoDELFIA Sample processor	Wallac OY	2
Asfa® Scanner	MBD Co., Ltd.	2
VICTOR2 D	Wallac OY	2
Seeker™	Baebies Inc.	2
Frend System	Nanoentek Inc	2

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
K923021	1992-07-21
K901674	1990-05-02

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.