JJG · Class I · 21 CFR 862.2140

FDA Product Code JJG: Analyzer, Chemistry, Centrifugal, For Clinical Use

Leading manufacturers include Union Carbide Corp., Roche Diagnostic Systems, Inc. and Beckman Instruments, Inc..

30
Total
30
Cleared
59d
Avg days
1977
Since

FDA 510(k) Cleared Analyzer, Chemistry, Centrifugal, For Clinical Use Devices (Product Code JJG)

30 devices
1–24 of 30
Cleared Jun 10, 1992
OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER
K920942
Olympus Corp.
Chemistry · 104d
Cleared Feb 27, 1991
COBAS ALPHA
K910222
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Oct 15, 1990
BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA
K903626
Beckman Instruments, Inc.
Chemistry · 66d
Cleared Aug 03, 1989
COBAS FARA II CENTRIFUGAL ANALYZER
K893854
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Jul 20, 1989
COBAS FARA CENTRIFUGAL ANALYZER
K893641
Roche Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Mar 28, 1989
TECHNICON DAX(TM) SYSTEM
K885203
Technicon Instruments Corp.
Chemistry · 99d
Cleared Jun 11, 1987
IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.
K871973
Instrumentation Laboratory CO
Chemistry · 20d
Cleared May 26, 1987
BIOMEK 1000C AUTOMATED LABORATORY WORK STATION
K871838
Beckman Instruments, Inc.
Chemistry · 14d
Cleared Jan 08, 1986
ANALYST PHYSICIAN'S OFFICE PROFILER
K854523
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 57d
Cleared Nov 27, 1984
COBAS FLUORESCENCE POLARIZATION MODULE
K843914
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Aug 02, 1984
PDA SYSTEM
K842522
Abbott Laboratories
Chemistry · 36d
Cleared Jun 30, 1983
REAGENT CUPS
K831569
American Scientific Products
Chemistry · 45d
Cleared Jun 30, 1983
ROTOR
K831571
American Scientific Products
Chemistry · 45d
Cleared Jun 18, 1981
FLEXIGRAM AUTO LOADER SYSTEM
K811525
Electro-Nucleonics Laboratories, Inc.
Chemistry · 20d
Cleared Jun 09, 1980
CENTRIFICHEM SYSTEM 500 ANALYZER
K801139
Union Carbide Corp.
Chemistry · 27d
Cleared May 28, 1980
IL MODEL 773 FLUORESCENCE LIGHT SCATTER
K801026
Instrumentation Laboratory CO
Chemistry · 27d
Cleared Jan 17, 1980
COBAS-BIO CENTRIFUGAL ANALYZER
K792671
Hoffmann-La Roche, Inc.
Chemistry · 21d
Cleared Aug 10, 1979
CENTRIFICHEM SYSTEM 500
K791180
Union Carbide Corp.
Chemistry · 46d
Cleared May 07, 1979
CENTRIA SYSTEM
K790550
Union Carbide Corp.
Chemistry · 48d
Cleared Apr 04, 1979
ANALYZER, CENTRIFUCHEM SYSTEM 400
K790278
Union Carbide Corp.
Chemistry · 54d

About Product Code JJG - Regulatory Context