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
73–96 of 258
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 Feb 23, 1990
BIOTRACK IMMUNOCHEMISTRY MONITOR
K900372
Biotrack, Inc.
Toxicology · 28d
Cleared Jan 22, 1990
ALLERCOAT MICROPLATE SYSTEM
K900028
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Dec 27, 1989
ACC.U.DIAL
K894423
Exocell, Inc.
Chemistry · 163d
Cleared Dec 19, 1989
COBAS READY
K896007
Roche Diagnostic Systems, Inc.
Chemistry · 67d
Cleared Nov 30, 1989
MODIFIED MODEL 535(TM) LUMINOMETER
K896117
Los Alamos Diagnostics
Chemistry · 41d
Cleared Oct 31, 1989
LP 400 MICROPLATE READER
K894859
Kallestad Diag, A Div. of Erbamont, Inc.
Chemistry · 92d
Cleared Oct 30, 1989
FASTEC 901 AGGLUTINATION PATTERN READER
K895967
Schiff & Co.
Microbiology · 18d
Cleared Oct 17, 1989
MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER
K895313
Dynatech Laboratories, Inc.
Chemistry · 49d
Cleared Oct 10, 1989
BIOTRACK PDS MONITOR
K895102
Biotrack, Inc.
Hematology · 56d
Cleared Sep 05, 1989
GEMTAB SYSTEM
K894503
Pharmacia Eni Diagnostics, Inc.
Chemistry · 48d
Cleared Aug 31, 1989
DYNATECH MR 5000, CATALOG #011-976-0600
K894687
Dynatech Laboratories, Inc.
Microbiology · 37d
Cleared Aug 21, 1989
DENLEY ANTHOS 2001 READER
K894270
Denley Instruments, Inc.
Chemistry · 60d
Cleared Aug 11, 1989
QUIDEL REFLECTANCE ANALYZER
K893738
Quidel Corp.
Chemistry · 86d
Cleared Jul 25, 1989
GENETIC SYSTEMS MICROPLATE READER
K891767
Genetic Systems Corp.
Chemistry · 123d
Cleared Jun 16, 1989
MICROTRAK EIA AUTOREADER
K891270
Syva Co.
Chemistry · 99d
Cleared May 11, 1989
THERMOMAX MICROPLATE READER, MODIFICATION
K892063
Molecular Devices Corp.
Chemistry · 42d
Cleared May 09, 1989
CLS 962 MICROPLATE PHOTOMETER
K891869
Cambridge Life Sciences Plc.
Chemistry · 43d
Cleared Mar 16, 1989
EIA READER MODEL EL301
K890854
Bio-Tek Instruments, Inc.
Chemistry · 23d
Cleared Feb 27, 1989
MICROLITE TUBE LUMINOMETER #011-902-0000
K890502
Dynatech Laboratories, Inc.
Chemistry · 26d
Cleared Feb 17, 1989
MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000)
K884782
Dynatech Laboratories, Inc.
Chemistry · 94d
Cleared Feb 10, 1989
PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO
K884864
The Perkin-Elmer Corp.
Toxicology · 80d
Cleared Jan 03, 1989
AUTOMATED EIA READER MODEL EL311
K884124
Bio-Tek Instruments, Inc.
Chemistry · 95d