Colorimeter, Photometer, Spectrophotometer For Clinical Use
FDA product code JJQ · 258 cleared devices
Class 1
Clinical Chemistry
- Regulation
- 21 CFR 862.2300
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-07-16 – 2001-12-21
JJQ
2001-12-21
JJQ
1998-02-06
DIGENE DML 2000 MICROPLATE LUMINOMETER
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JJQ
1998-02-04
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
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JJQ
1998-01-28
STAT TRACKS
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JJQ
1996-11-05
ANTHOS PHACTS VERSION MICROPLATE READER
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JJQ
1996-08-02
CBI 7520 READER
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JJQ
1996-07-31
ORIGEN ANALYZER
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JJQ
1995-12-04
ANTHOS 2010 READER
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JJQ
1995-10-25
ELX808 AUTOMATED MICROPLATE READERS
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JJQ
1995-10-19
ELX800UV
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JJQ
1995-09-28
BILI-METER
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JJQ
1995-08-02
5STRATEC SL 300 LIA-MAT
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JJQ
1995-04-18
DIGENE DCR-1 LUMINOMETER
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JJQ
1995-04-04
WHITSOFT
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JJQ
1995-04-04
BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER
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JJQ
1995-04-03
BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE
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JJQ
1995-03-21
ELX800 AND EL800 AUTOMATED MICROPLATE READERS
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JJQ
1995-02-06
CERES 900C & CERES UV900C
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JJQ
1995-01-09
PLATO 3300/1300
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JJQ
1994-12-09
MICROREADER 4
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JJQ
1994-11-28
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM
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JJQ
1994-11-10
DUPONT ACA STAR
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JJQ
1994-10-20
MRX MICROPLATE READER
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JJQ
1993-11-17
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
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JJQ
1993-11-05
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM
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JJQ
1993-10-12
ACCULYTE CHEMILUMINESCENCE ANALYZER
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JJQ
1993-09-29
ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III
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JJQ
1993-08-19
OMNI
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JJQ
1993-04-22
OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER
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JJQ
1992-12-11
LYRIS 100/120 LABORATORY INFORMATION SYSTEM
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JJQ
1992-11-25
TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1
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JJQ
1992-11-17
LUMICO ANALYZER SA-300
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JJQ
1992-11-16
LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT
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JJQ
1992-11-16
BERTHOLD LB 954
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JJQ
1992-10-13
MICROLITE MICROTITER PLATE LUMINOMETER ML3000
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JJQ
1992-09-02
LABOTECH AUTOMATED MICROTITER ANALYZER
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JJQ
1992-07-28
COBAS CORE IMMUNOCHEMISTRY SYSTEM
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JJQ
1992-05-04
MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI
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JJQ
1992-04-22
SLT 340 ATTC
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JJQ
1992-04-22
SLT SPECTRA
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JJQ
1992-03-23
MP/S SINGLE WAVELENGTH MINI PHOTOMETER
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JJQ
1992-03-18
ENCORE
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JJQ
1992-03-11
AMERLITE PROCESSING CENTER
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JJQ
1991-11-27
AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT
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JJQ
1991-10-25
MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER
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JJQ
1991-10-11
BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE
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JJQ
1991-09-30
MICROTAK PLUS
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JJQ
1991-09-11
OPUS(R) PLUS ANALYZER
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JJQ
1991-09-11
IMX SELECT ANALYZER
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JJQ
1991-08-30
METROLAB MODEL 1500
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JJQ
1991-07-26
MICROTRAK MANAGER
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JJQ
1991-07-01
CHEM-LINK DATA BASE MANAGER
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JJQ
1991-06-24
OBA(TM) READER
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JJQ
1991-05-23
TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE
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JJQ
1991-04-18
DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER
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JJQ
1991-03-27
SLT MICROPLATE WASHER
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JJQ
1991-02-22
ECLIPSE ICA ANALYZER
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JJQ
1991-01-28
DYNATECH MR4000 MICROPLATE READER
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JJQ
1991-01-23
GEN-PROBE LUMINOMETER-LEADER 450
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JJQ
1991-01-11
IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER
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JJQ
1990-10-04
GEN-PROBE PAL LUMINOMETER
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JJQ
1990-09-27
GEN-PROBE LUMINOMETER-LEADER 50
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JJQ
1990-08-09
EURAMARK 610 PHOTOMETER
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JJQ
1990-07-31
SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
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JJQ
1990-07-24
BEHRING CHROMOTIMER
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JJQ
1990-05-24
QUICK CHEM II
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JJQ
1990-05-10
MPR-4A - MICRO-PLATE READER
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JJQ
1990-04-26
E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE
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JJQ
1990-04-11
DU PONT VISTA(R) IMMUNOASSAY SYSTEM
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JJQ
1990-04-09
AUTOMATED EIA MICROPLATE READER MODELS EL340/340I
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JJQ
1990-04-09
AUTOMATED EIA MICROPLATE READER MODELS EL312/312I
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JJQ
1990-04-03
NOVAPATH MICROPLATE READER
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JJQ
1990-03-01
STAT FAX(TM)-2100
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JJQ
1990-02-27
AUTOREADER CALIBRATION TEST PLATE
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JJQ
1990-02-23
BIOTRACK IMMUNOCHEMISTRY MONITOR
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JJQ
1990-01-22
ALLERCOAT MICROPLATE SYSTEM
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JJQ
1989-12-27
ACC.U.DIAL
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JJQ
1989-12-19
COBAS READY
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JJQ
1989-11-30
MODIFIED MODEL 535(TM) LUMINOMETER
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JJQ
1989-10-31
LP 400 MICROPLATE READER
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JJQ
1989-10-30
FASTEC 901 AGGLUTINATION PATTERN READER
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JJQ
1989-10-17
MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER
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JJQ
1989-10-10
BIOTRACK PDS MONITOR
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JJQ
1989-09-05
GEMTAB SYSTEM
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JJQ
1989-08-31
DYNATECH MR 5000, CATALOG #011-976-0600
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JJQ
1989-08-21
DENLEY ANTHOS 2001 READER
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JJQ
1989-08-11
QUIDEL REFLECTANCE ANALYZER
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JJQ
1989-07-25
GENETIC SYSTEMS MICROPLATE READER
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JJQ
1989-06-16
MICROTRAK EIA AUTOREADER
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JJQ
1989-05-11
THERMOMAX MICROPLATE READER, MODIFICATION
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JJQ
1989-05-09
CLS 962 MICROPLATE PHOTOMETER
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JJQ
1989-03-16
EIA READER MODEL EL301
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JJQ
1989-02-27
MICROLITE TUBE LUMINOMETER #011-902-0000
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JJQ
1989-02-17
MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000)
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JJQ
1989-02-10
PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO
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JJQ
1989-01-03
AUTOMATED EIA READER MODEL EL311
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JJQ
1988-10-31
BEHRING TURBITIMER
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JJQ
1988-10-13
NOVASPEC II SPECTROPHOTOMETER
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JJQ
1988-09-13
EMAX PRECISION MICROPLATE READER
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JJQ
1988-09-09
STAT FAX(TM)
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