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
57 devices
25–48 of 57
Cleared May 08, 1987
(FPIA) ASSAY BUFFER
K871486
Windsor Laboratories, Inc.
Chemistry · 23d
Cleared Mar 13, 1987
SYVA ETS SYSTEM
K863245
Syva Co.
Chemistry · 203d
Cleared Mar 13, 1987
PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER
K870777
Kone Instruments, Inc.
Chemistry · 15d
Cleared Feb 20, 1987
OLYMPUS PK300
K864834
Olympus Corp.
Chemistry · 73d
Cleared Dec 31, 1986
SYNCHRON CX3
K864236
Beckman Instruments, Inc.
Chemistry · 64d
Cleared Jul 12, 1985
HYBRITECH IMMUNOCHEMISTRY ANALYZER
K852385
Hybritech, Inc.
Chemistry · 37d
Cleared Jun 10, 1985
CLINICAL CHEMISTRY ANALYTICAL SYSTEM
K851933
Allied Instrumentation Laboratory
Chemistry · 39d
Cleared May 10, 1985
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K851542
Alpkem Corp.
Chemistry · 24d
Cleared May 02, 1985
COBAS MIRA
K851172
Roche Diagnostic Systems, Inc.
Chemistry · 41d
Cleared Apr 08, 1985
TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN
K850999
Technicon Instruments Corp.
Chemistry · 28d
Cleared Dec 11, 1984
IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS
K844586
Instrumentation Laboratory CO
Chemistry · 18d
Cleared Apr 04, 1984
PROGRESS SELECTIVE DHEMISTRY ANALYZ
K840200
Kone Instruments, Inc.
Chemistry · 76d
Cleared Jan 30, 1984
QCA CHEMISTRY ANALYZER
K833998
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 70d
Cleared Jan 13, 1984
SHABAN 9865 IL#78637 JUNCTION BLOC
K833804
Shaban Mfg. Co.
Chemistry · 73d
Cleared Dec 08, 1983
NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM
K833154
Nova Biomedical Corp.
Chemistry · 84d
Cleared Nov 25, 1983
NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU
K833153
Nova Biomedical Corp.
Chemistry · 71d
Cleared Jun 02, 1983
COMPUR EASY TOUCH CHEMISTRY ANALYZER-
K831227
Worthington Diagnostic Systems
Chemistry · 48d
Cleared Jan 28, 1983
RAPID CHEM ANALYZER II
K830095
Macomb Chemical Co.
Toxicology · 17d
Cleared Jun 24, 1982
AMES/GILFORD OPTIMATE CLIN. CHEM & THER
K821583
Gilford Instrument Laboratories, Inc.
Chemistry · 27d
Cleared May 24, 1982
MICROLYTE
K820541
Kone Instruments, Inc.
Chemistry · 83d
Cleared Apr 06, 1982
POLI-MAK MODEL F-4 (FINAL
K820748
Pm America, Inc.
Chemistry · 18d
Cleared Mar 11, 1982
4150 ALPHA AMINO ACID ANALYZER
K820415
Lkb Instruments, Inc.
Chemistry · 27d
Cleared Dec 22, 1980
AMINO ACID ANALYSER SYSTEM
K803004
Lkb Instruments, Inc.
Chemistry · 26d
Cleared Oct 31, 1980
WASH SOLUTION KIT, #88102
K802264
Hi Chem, Inc.
Chemistry · 45d