JJQ · Class I · 21 CFR 862.2300

FDA Product Code JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use

Leading manufacturers include Dynatech Laboratories, Inc., Bio-Tek Instruments, Inc. and Awareness Technology, Inc..

258
Total
258
Cleared
71d
Avg days
1976
Since
258 devices
25–48 of 258
Cleared Mar 18, 1992
ENCORE
K915113
Heraeus Kulzer, Inc.
Chemistry · 126d
Cleared Mar 11, 1992
AMERLITE PROCESSING CENTER
K915680
Eastman Kodak Company
Chemistry · 83d
Cleared Nov 27, 1991
AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT
K914906
Bio-Tek Instruments, Inc.
Chemistry · 26d
Cleared Oct 25, 1991
MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER
K913590
Dynatech Laboratories, Inc.
Chemistry · 74d
Cleared Oct 11, 1991
BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE
K914202
Baxter Diagnostics, Inc.
Chemistry · 22d
Cleared Sep 30, 1991
MICROTAK PLUS
K913840
Syva Co.
Chemistry · 35d
Cleared Sep 11, 1991
IMX SELECT ANALYZER
K912368
Abbott Laboratories
Chemistry · 105d
Cleared Sep 11, 1991
OPUS(R) PLUS ANALYZER
K913295
Pb Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Jul 26, 1991
MICROTRAK MANAGER
K912959
Syva Co.
Chemistry · 18d
Cleared Jul 01, 1991
CHEM-LINK DATA BASE MANAGER
K912413
Technicon Instruments Corp.
Chemistry · 31d
Cleared May 23, 1991
TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE
K911438
Bio-Tek Instruments, Inc.
Chemistry · 51d
Cleared Jan 28, 1991
DYNATECH MR4000 MICROPLATE READER
K904567
Dynatech Corp.
Microbiology · 111d
Cleared Jan 23, 1991
GEN-PROBE LUMINOMETER-LEADER 450
K905762
Gen-Probe, Inc.
Chemistry · 27d
Cleared Oct 04, 1990
GEN-PROBE PAL LUMINOMETER
K903911
Gen-Probe, Inc.
Chemistry · 41d
Cleared Sep 27, 1990
GEN-PROBE LUMINOMETER-LEADER 50
K903934
Gen-Probe, Inc.
Chemistry · 31d
Cleared Jul 24, 1990
BEHRING CHROMOTIMER
K901829
Behring Diagnostics, Inc.
Hematology · 91d
Cleared May 24, 1990
QUICK CHEM II
K901695
Seradyn, Inc.
Chemistry · 44d
Cleared Apr 11, 1990
DU PONT VISTA(R) IMMUNOASSAY SYSTEM
K900245
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 84d
Cleared Apr 09, 1990
AUTOMATED EIA MICROPLATE READER MODELS EL312/312I
K901027
Bio-Tek Instruments, Inc.
Chemistry · 34d
Cleared Apr 09, 1990
AUTOMATED EIA MICROPLATE READER MODELS EL340/340I
K901059
Bio-Tek Instruments, Inc.
Chemistry · 34d
Cleared Apr 03, 1990
NOVAPATH MICROPLATE READER
K900776
Bio-Rad
Chemistry · 42d
Cleared Mar 01, 1990
STAT FAX(TM)-2100
K900224
Awareness Technology, Inc.
Chemistry · 43d
Cleared Feb 27, 1990
AUTOREADER CALIBRATION TEST PLATE
K900579
Bio-Tek Instruments, Inc.
Chemistry · 20d
Cleared Jan 22, 1990
ALLERCOAT MICROPLATE SYSTEM
K900028
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d