JJC · Class I · 21 CFR 862.2150

FDA Product Code JJC: Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use

Leading manufacturers include Technicon Instruments Corp., Gilford Instrument Laboratories, Inc. and Methodist Hospital of Memphis.

32
Total
32
Cleared
63d
Avg days
1976
Since

FDA 510(k) Cleared Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use Devices (Product Code JJC)

32 devices
1–24 of 32
Cleared Apr 05, 1995
AVL OMNI ANALYZER
K945915
Avl Scientific Corp.
Chemistry · 124d
Cleared Feb 08, 1995
NOVA 16 ANALYZER
K945584
Nova Biomedical Corp.
Chemistry · 86d
Cleared Sep 14, 1994
OPERA SYSTEM
K943376
Miles, Inc.
Chemistry · 63d
Cleared Jul 17, 1990
TECHNICON RA-2000(TM) SYSTEM
K901410
Technicon Instruments Corp.
Chemistry · 113d
Cleared Apr 09, 1990
PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX
K901141
Baxter Healthcare Corp
Chemistry · 27d
Cleared Feb 17, 1989
RFA/2 RAPID FLOW ANALYZER W/COMPUTER
K890332
Alpkem Corp.
Chemistry · 25d
Cleared Nov 15, 1988
AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030
K881056
American Research Products Co.
Chemistry · 249d
Cleared Feb 16, 1988
TECHNICON SMAC 3 SYSTEM
K875105
Technicon Instruments Corp.
Chemistry · 64d
Cleared May 26, 1987
TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS
K870998
Technicon Instruments Corp.
Chemistry · 76d
Cleared Oct 20, 1986
TECHNICON RA-XT SYSTEM WITH ANALYTES
K862561
Technicon Instruments Corp.
Chemistry · 109d
Cleared Nov 26, 1985
TECHNICON RA-500 SYSTEM
K854345
Technicon Instruments Corp.
Chemistry · 29d
Cleared Aug 02, 1985
REPLACEMENT REAGENTS FOR SMAC II SYSTEMS
K852306
Methodist Hospital of Memphis
Chemistry · 65d
Cleared Dec 08, 1983
LANCER ANALYZER CUPS
K833157
Sherwood Medical Co.
Chemistry · 83d
Cleared Nov 03, 1983
TECHNICON RA-1000 SYSTEM
K833023
Technicon Instruments Corp.
Chemistry · 58d
Cleared Nov 29, 1982
SBA 300 CLINICAL CHEMISTRY ANALYZER
K823233
Gilford Instrument Laboratories, Inc.
Chemistry · 31d
Cleared Nov 16, 1981
TECHNICON RA 1000 SYSTEM
K813077
Technicon Corp.
Chemistry · 14d
Cleared May 21, 1981
TECHNICON SMAC II SYSTEM & ACCESSORIES
K811249
Technicon Instruments Corp.
Chemistry · 16d
Cleared Mar 06, 1981
PRE-VAP CAPS
K810394
Sherman Boosalis
Chemistry · 16d
Cleared Aug 20, 1980
BMC RIAFLO SYSTEM
K801481
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Aug 08, 1980
NSI WASH SOLUTION CONCENTRATE
K800587
Nobel Scientific Industries, Inc.
Chemistry · 144d
Cleared Mar 20, 1980
PHOTOVOLT PVA 4M+2 ANALYZER
K800453
Photovolt Corp.
Chemistry · 20d
Cleared Dec 06, 1979
TECHNICON C800 SYSTEM
K792285
Technicon Instruments Corp.
Chemistry · 23d
Cleared Sep 27, 1978
TECHNICON STAT/LYTE ISE ELECTROLYTE
K781503
Technicon Instruments Corp.
Chemistry · 28d
Cleared Dec 06, 1977
AUTOMATIC ANALYZER
K771662
Lachat Chemicals, Inc.
Chemistry · 98d

About Product Code JJC - Regulatory Context