Who else makes this device?

Name: Cardiac CalVer for Abbott Systems, Level A-E
Brand: Cardiac CalVer for Abbott Systems, Level A-E

Clinical Chemistry › Test SystemsMulti-Analyte Controls, All Kinds (Assayed)

Cardiac CalVer for Abbott Systems, Level A-E

LiniCAL Cardiac CalVer for Abbott Systems, Level A LiniCAL Cardiac CalVer for Abbott Systems, Level B LiniCAL Cardiac CalVer for Abbott Systems, Level C LiniCAL Cardiac CalVer for Abbott…

Registry build 21.09.26

LiniCAL Cardiac CalVer for Abbott Systems, Level A LiniCAL Cardiac CalVer for Abbott Systems, Level B LiniCAL Cardiac CalVer for Abbott Systems, Level C LiniCAL Cardiac CalVer for Abbott Systems, Level D LiniCAL Cardiac CalVer for Abbott Systems, Level E

1manufacturer

1catalogue number

22510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JJY
Manufacturer	City	Province	Registered as	Device types
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19

Record

Regulatory record for Cardiac CalVer for Abbott Systems, Level A-E
Listed by	Cliniqa Corporation, United States
FDA product code	JJY
Device type	Multi-Analyte Controls, All Kinds (Assayed)
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
510(k)	K080973
Record published	2020-07-31
Record revised	2020-08-31 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2020-08-31

Catalogue Numbers

Catalogue numbers for Cardiac CalVer for Abbott Systems, Level A-E
Catalogue number	Size	Status
98602		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Liquichek	Bio-Rad Laboratories Inc.	154
Validate	LGC Clinical Diagnostics, Inc.	120
InteliQ	Bio-Rad Laboratories Inc.	50
Lyphochek	Bio-Rad Laboratories Inc.	39
Stat Profile	Nova Biomedical Corporation	38
i-STAT	Abbott Point OF Care Inc.	24
Multichem AE	Techno-Path Manufacturing Ltd.	20
Serum Control	Chromsystems Instruments & Chemicals Gmbh	18
BioPlex 2200	Bio-Rad Laboratories Inc.	16
Nova	Nova Biomedical Corporation	14
Plasma Control	Chromsystems Instruments & Chemicals Gmbh	14
Multichem IA Speciality	Techno-Path Manufacturing Ltd.	12

Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K083554	2009-04-21
K082107	2008-09-17
K080973	2008-06-02
K070741	2007-05-04
K062916	2006-10-23
K061182	2006-05-25
K040535	2004-03-29
K040091	2004-02-23
K032074	2003-10-21
K033162	2003-10-10
K031921	2003-08-25
K031577	2003-08-06
K031575	2003-07-23
K030705	2003-03-26
K030566	2003-03-13
K030150	2003-01-28
K023661	2002-12-06
K023250	2002-10-17
K022885	2002-10-02
K022936	2002-10-02
K022867	2002-10-02
K013332	2001-11-20

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.