Who else makes this device?

Name: cobas c 501 Module
Brand: cobas c 501 Module

Clinical Chemistry › Laboratory InstrumentsAnalyzer, Chemistry, Micro, For Clinical Use

Cobas C 501 Module

Catalogue number 4745914001, listed by Roche Diagnostics Gmbh, Germany, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Jiangsu (1), Hubei (1), Henan (1).

Chinese manufacturers registered for FDA product code JJF
Manufacturer	City	Province	Registered as	Device types
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19
Wuhan Landing Intelligence Medical Co., Ltd.	Wuhan	Hubei	Manufacturer	17
Autobio Labtec Instruments Co., Ltd.	Zhengzhou	Henan	Manufacturer	3

Record

Regulatory record for cobas c 501 Module
Listed by	Roche Diagnostics Gmbh, Germany
FDA product code	JJF
Device type	Analyzer, Chemistry, Micro, For Clinical Use
Device class	Class 1
Regulation	21 CFR 862.2170
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K060373
Record published	2016-09-20
Record revised	2022-12-08 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Distribution end date	2018-07-01

Catalogue Numbers

Catalogue numbers for cobas c 501 Module
Catalogue number	Size	Status
4745914001		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Diamedix	Diamedix Corp.	2
Spotcheck	Astoria-Pacific, Inc.	2
Cholestech LDX™	Alere San Diego, Inc.	2
AWS	Randox Laboratories Limited	1
Liaison® XL	Diasorin Inc.	1
COBAS®TaqMan® 48 Analyzer	Roche Molecular Systems, Inc.	1
Soln Wash	Randox Laboratories Limited	1
Wash conc. 1	Randox Laboratories Limited	1
NS	Randox Laboratories Limited	1
Liaison® Easy Starter Kit	Diasorin S.P.A	1
Rabs	Randox Laboratories Limited	1
Cl Soln	Randox Laboratories Limited	1

Showing 12 of 26. All products under Analyzer, Chemistry, Micro, For Clinical Use

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K033734	2003-12-17

Recalls

The FDA has not published a severity grade for these. 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
2007-08-30	Not classified	Process design	False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The affected capillaries showed up to a 40% reduction in signal	119 boxes of 96 capillaries each	2008-09-08

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.