JJF · Class I · 21 CFR 862.2170

FDA Product Code JJF: Analyzer, Chemistry, Micro, For Clinical Use

Leading manufacturers include Technicon Instruments Corp., Beckman Instruments, Inc. and Syva Co..

57
Total
57
Cleared
85d
Avg days
1977
Since

FDA 510(k) Cleared Analyzer, Chemistry, Micro, For Clinical Use Devices (Product Code JJF)

57 devices
1–24 of 57
Cleared Mar 31, 2006
ETI-MAX 3000
K052794
DiaSorin, Inc.
Immunology · 179d
Cleared Jun 16, 2004
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
K040332
Arkray, Inc.
Chemistry · 127d
Cleared Dec 17, 2003
LIGHTCYCLER INSTRUMENT VERSION 1.2
K033734
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Jun 05, 2002
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
K013654
Precision Systems, Inc.
Toxicology · 211d
Cleared Feb 01, 2002
ROCHE COBAS TAQMAN ANALYZER
K012966
Roche Molecular Systems, Inc.
Chemistry · 150d
Cleared Dec 02, 1999
CARESIDE ANALYZER
K993634
Careside, Inc.
Chemistry · 36d
Cleared Mar 13, 1998
VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA
K973628
Vital Scientific N.V.
Chemistry · 170d
Cleared Mar 06, 1998
CARESIDE ANALYZER
K980056
Exigent Diagnostics, Inc.
Chemistry · 59d
Cleared Oct 09, 1997
MAGO AUTOMATED EIA PROCESSOR
K973177
Diamedix Corp.
Chemistry · 45d
Cleared Jun 26, 1997
SYNERMED IR 200 CHEMISTRY ANALYZER
K971491
Synermed, Inc.
Chemistry · 63d
Cleared May 21, 1997
ROCHE COBAS AMPLICOR ANALYZER
K964506
Roche Molecular Systems, Inc.
Chemistry · 194d
Cleared May 09, 1997
WINMAX SOFTWARE SYSTEMS
K965103
Diagnostic Products Corp.
Chemistry · 140d
Cleared Jan 22, 1997
HCL - 200 BIOCHEMISTRY ANALYZER
K964409
Hcl Laboratory Systems, Inc.
Chemistry · 79d
Cleared Dec 24, 1996
BRIO AUTOMATIC SAMPLINC UNIT
K961209
Seac S.R.L.
Chemistry · 271d
Cleared May 02, 1995
WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS
K943978
Waters Chromatography Division
Chemistry · 259d
Cleared Nov 02, 1994
SYNCHRON CX3 DELTA
K942676
Beckman-Diagnostic Systems Group
Chemistry · 149d
Cleared Nov 16, 1993
SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA
K925093
Beckman Instruments, Inc.
Chemistry · 405d
Cleared Jun 10, 1991
SYVA EDMS
K912055
Syva Co.
Chemistry · 32d
Cleared Sep 27, 1990
SYVA(R) ETS(R) PLUS SYSTEM
K903357
Syva Co.
Chemistry · 63d
Cleared Aug 15, 1989
MODIFIED PK300 AUTOMATIC EIA ANALYZER
K893768
Olympus Corp.
Chemistry · 88d
Cleared Mar 16, 1989
RECONDITIONED ASTRA (TM) 8
K883298
Associated Electro-Medical Services, Inc.
Chemistry · 224d
Cleared Mar 16, 1989
RECONDITIONED ASTRA(TM) 4
K883350
Associated Electro-Medical Services, Inc.
Chemistry · 219d
Cleared Sep 02, 1988
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K883020
Alpkem Corp.
Chemistry · 45d
Cleared Oct 28, 1987
SERALYZER III BLOOD CHEMISTRY ANALYZER
K872120
Miles Laboratories, Inc.
Chemistry · 149d

About Product Code JJF - Regulatory Context