FDA Product Code
FDA Product Code JJQ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2300
510(k) Clearances — 258 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K013371 | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM | Otsuka Pharmaceutical Co., Ltd. | 2001-12-21 | Traditional | PDF ↗ |
| K980120 | DIGENE DML 2000 MICROPLATE LUMINOMETER | Digene Corp. | 1998-02-06 | Traditional | PDF ↗ |
| K973938 | ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER | Sfri, Inc. | 1998-02-04 | Traditional | PDF ↗ |
| K974762 | STAT TRACKS | Awareness Technology, Inc. | 1998-01-28 | Traditional | PDF ↗ |
| K962113 | ANTHOS PHACTS VERSION MICROPLATE READER | Columbia Bioscience, Inc. | 1996-11-05 | Traditional | PDF ↗ |
| K961183 | CBI 7520 READER | Columbia Bioscience, Inc. | 1996-08-02 | Traditional | PDF ↗ |
| K962166 | ORIGEN ANALYZER | Igen, Inc. | 1996-07-31 | Traditional | PDF ↗ |
| K955077 | ANTHOS 2010 READER | Anthos Labtec, Inc. | 1995-12-04 | Traditional | PDF ↗ |
| K953710 | ELX808 AUTOMATED MICROPLATE READERS | Bio-Tek Instruments, Inc. | 1995-10-25 | Traditional | PDF ↗ |
| K953572 | ELX800UV | Bio-Tek Instruments, Inc. | 1995-10-19 | Traditional | PDF ↗ |
| K953005 | BILI-METER | Olympic Medical Corp. | 1995-09-28 | Traditional | PDF ↗ |
| K950029 | 5STRATEC SL 300 LIA-MAT | Nichols Institute Diagnostics | 1995-08-02 | Traditional | PDF ↗ |
| K940486 | DIGENE DCR-1 LUMINOMETER | Digene Diagnostics, Inc. | 1995-04-18 | Traditional | PDF ↗ |
| K942361 | WHITSOFT | Biowhittaker Molecular Applications, Inc. | 1995-04-04 | Traditional | PDF ↗ |
| K942250 | BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER | Biowhittaker Molecular Applications, Inc. | 1995-04-04 | Traditional | PDF ↗ |
| K942245 | BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE | Biowhittaker Molecular Applications, Inc. | 1995-04-03 | Traditional | PDF ↗ |
| K950104 | ELX800 AND EL800 AUTOMATED MICROPLATE READERS | Bio-Tek Instruments, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K942923 | CERES 900C & CERES UV900C | Bio-Tek Instruments, Inc. | 1995-02-06 | Traditional | PDF ↗ |
| K943454 | PLATO 3300/1300 | Rosys, Inc. | 1995-01-09 | Traditional | PDF ↗ |
| K935983 | MICROREADER 4 | Hyperion, Inc. | 1994-12-09 | Traditional | PDF ↗ |
| K943595 | SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM | Instrumentation Laboratory CO | 1994-11-28 | Traditional | PDF ↗ |
| K941050 | DUPONT ACA STAR | Dupont Medical Products | 1994-11-10 | Traditional | PDF ↗ |
| K943701 | MRX MICROPLATE READER | Dynatech Laboratories, Inc. | 1994-10-20 | Traditional | PDF ↗ |
| K932778 | BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER | Boehringer Mannheim Corp. | 1993-11-17 | Traditional | PDF ↗ |
| K932467 | ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM | Instrumentation Laboratory CO | 1993-11-05 | Traditional | PDF ↗ |
| K921536 | ACCULYTE CHEMILUMINESCENCE ANALYZER | Laboratory Technologies, Inc. | 1993-10-12 | Traditional | PDF ↗ |
| K931907 | ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III | Anthos Labtec Instruments | 1993-09-29 | Traditional | PDF ↗ |
| K925625 | OMNI | Bio-Tek Instruments, Inc. | 1993-08-19 | Traditional | PDF ↗ |
| K925935 | OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER | Olympus Corp. | 1993-04-22 | Traditional | PDF ↗ |
| K923844 | LYRIS 100/120 LABORATORY INFORMATION SYSTEM | Biovation, Inc. | 1992-12-11 | Traditional | PDF ↗ |
| K925203 | TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 | Heraeus Kulzer, Inc. | 1992-11-25 | Traditional | PDF ↗ |
| K923158 | LUMICO ANALYZER SA-300 | Maruzen Petrochemical Co., Ltd. | 1992-11-17 | Traditional | PDF ↗ |
| K922976 | LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT | Eg&G Berthold Analytical Instruments, Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K922329 | BERTHOLD LB 954 | Eg&G Berthold Analytical Instruments, Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K923456 | MICROLITE MICROTITER PLATE LUMINOMETER ML3000 | Dynatech Laboratories, Inc. | 1992-10-13 | Traditional | PDF ↗ |
| K922081 | LABOTECH AUTOMATED MICROTITER ANALYZER | Innovative Medical Systems, Inc. | 1992-09-02 | Traditional | PDF ↗ |
| K921180 | COBAS CORE IMMUNOCHEMISTRY SYSTEM | Roche Diagnostic Systems, Inc. | 1992-07-28 | Traditional | PDF ↗ |
| K915896 | MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI | Dynatech Laboratories, Inc. | 1992-05-04 | Traditional | PDF ↗ |
| K915690 | SLT 340 ATTC | Slt Labinstruments, Inc. | 1992-04-22 | Traditional | PDF ↗ |
| K915689 | SLT SPECTRA | Slt Labinstruments, Inc. | 1992-04-22 | Traditional | PDF ↗ |
| K920914 | MP/S SINGLE WAVELENGTH MINI PHOTOMETER | Artel, Inc. | 1992-03-23 | Traditional | PDF ↗ |
| K915113 | ENCORE | Heraeus Kulzer, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K915680 | AMERLITE PROCESSING CENTER | Eastman Kodak Company | 1992-03-11 | Traditional | PDF ↗ |
| K914906 | AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT | Bio-Tek Instruments, Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K913590 | MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER | Dynatech Laboratories, Inc. | 1991-10-25 | Traditional | PDF ↗ |
| K914202 | BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE | Baxter Diagnostics, Inc. | 1991-10-11 | Traditional | PDF ↗ |
| K913840 | MICROTAK PLUS | Syva Co. | 1991-09-30 | Traditional | PDF ↗ |
| K913295 | OPUS(R) PLUS ANALYZER | Pb Diagnostic Systems, Inc. | 1991-09-11 | Traditional | PDF ↗ |
| K912368 | IMX SELECT ANALYZER | Abbott Laboratories | 1991-09-11 | Traditional | PDF ↗ |
| K910806 | METROLAB MODEL 1500 | Laboratorio Rodriguez Corswant S.R.L. | 1991-08-30 | Traditional | PDF ↗ |
| K912959 | MICROTRAK MANAGER | Syva Co. | 1991-07-26 | Traditional | PDF ↗ |
| K912413 | CHEM-LINK DATA BASE MANAGER | Technicon Instruments Corp. | 1991-07-01 | Traditional | PDF ↗ |
| K911045 | OBA(TM) READER | Adeza Biomedical | 1991-06-24 | Traditional | PDF ↗ |
| K911438 | TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE | Bio-Tek Instruments, Inc. | 1991-05-23 | Traditional | PDF ↗ |
| K904783 | DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER | Industrial Chemical Measurement | 1991-04-18 | Traditional | PDF ↗ |
| K910740 | SLT MICROPLATE WASHER | Tecan U.S., Ltd. | 1991-03-27 | Traditional | PDF ↗ |
| K910302 | ECLIPSE ICA ANALYZER | Biotope, Inc. | 1991-02-22 | Traditional | PDF ↗ |
| K904567 | DYNATECH MR4000 MICROPLATE READER | Dynatech Corp. | 1991-01-28 | Traditional | PDF ↗ |
| K905762 | GEN-PROBE LUMINOMETER-LEADER 450 | Gen-Probe, Inc. | 1991-01-23 | Traditional | PDF ↗ |
| K905215 | IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER | Cirrus Diagnostics, Inc. | 1991-01-11 | Traditional | PDF ↗ |
| K903911 | GEN-PROBE PAL LUMINOMETER | Gen-Probe, Inc. | 1990-10-04 | Traditional | PDF ↗ |
| K903934 | GEN-PROBE LUMINOMETER-LEADER 50 | Gen-Probe, Inc. | 1990-09-27 | Traditional | PDF ↗ |
| K903164 | EURAMARK 610 PHOTOMETER | Euro-American Marketing Group, Inc. | 1990-08-09 | Traditional | PDF ↗ |
| K902776 | SPECTROPHOTOMETER (MICROASSAY PLATE READERS) | Slt Labinstruments, Inc. | 1990-07-31 | Traditional | PDF ↗ |
| K901829 | BEHRING CHROMOTIMER | Behring Diagnostics, Inc. | 1990-07-24 | Traditional | PDF ↗ |
| K901695 | QUICK CHEM II | Seradyn, Inc. | 1990-05-24 | Traditional | PDF ↗ |
| K901965 | MPR-4A - MICRO-PLATE READER | Tosoh Corp. | 1990-05-10 | Traditional | PDF ↗ |
| K901542 | E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE | Source Scientific Systems, Inc. | 1990-04-26 | Traditional | PDF ↗ |
| K900245 | DU PONT VISTA(R) IMMUNOASSAY SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | 1990-04-11 | Traditional | PDF ↗ |
| K901027 | AUTOMATED EIA MICROPLATE READER MODELS EL312/312I | Bio-Tek Instruments, Inc. | 1990-04-09 | Traditional | PDF ↗ |
| K901059 | AUTOMATED EIA MICROPLATE READER MODELS EL340/340I | Bio-Tek Instruments, Inc. | 1990-04-09 | Traditional | PDF ↗ |
| K900776 | NOVAPATH MICROPLATE READER | Bio-Rad | 1990-04-03 | Traditional | PDF ↗ |
| K900224 | STAT FAX(TM)-2100 | Awareness Technology, Inc. | 1990-03-01 | Traditional | PDF ↗ |
| K900579 | AUTOREADER CALIBRATION TEST PLATE | Bio-Tek Instruments, Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K900372 | BIOTRACK IMMUNOCHEMISTRY MONITOR | Biotrack, Inc. | 1990-02-23 | Traditional | PDF ↗ |
| K900028 | ALLERCOAT MICROPLATE SYSTEM | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K894423 | ACC.U.DIAL | Exocell, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K896007 | COBAS READY | Roche Diagnostic Systems, Inc. | 1989-12-19 | Traditional | PDF ↗ |
| K896117 | MODIFIED MODEL 535(TM) LUMINOMETER | Los Alamos Diagnostics | 1989-11-30 | Traditional | PDF ↗ |
| K894859 | LP 400 MICROPLATE READER | Kallestad Diag, A Div. of Erbamont, Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K895967 | FASTEC 901 AGGLUTINATION PATTERN READER | Schiff & Co. | 1989-10-30 | Traditional | PDF ↗ |
| K895313 | MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER | Dynatech Laboratories, Inc. | 1989-10-17 | Traditional | PDF ↗ |
| K895102 | BIOTRACK PDS MONITOR | Biotrack, Inc. | 1989-10-10 | Traditional | PDF ↗ |
| K894503 | GEMTAB SYSTEM | Pharmacia Eni Diagnostics, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K894687 | DYNATECH MR 5000, CATALOG #011-976-0600 | Dynatech Laboratories, Inc. | 1989-08-31 | Traditional | PDF ↗ |
| K894270 | DENLEY ANTHOS 2001 READER | Denley Instruments, Inc. | 1989-08-21 | Traditional | PDF ↗ |
| K893738 | QUIDEL REFLECTANCE ANALYZER | Quidel Corp. | 1989-08-11 | Traditional | PDF ↗ |
| K891767 | GENETIC SYSTEMS MICROPLATE READER | Genetic Systems Corp. | 1989-07-25 | Traditional | PDF ↗ |
| K891270 | MICROTRAK EIA AUTOREADER | Syva Co. | 1989-06-16 | Traditional | PDF ↗ |
| K892063 | THERMOMAX MICROPLATE READER, MODIFICATION | Molecular Devices Corp. | 1989-05-11 | Traditional | PDF ↗ |
| K891869 | CLS 962 MICROPLATE PHOTOMETER | Cambridge Life Sciences Plc. | 1989-05-09 | Traditional | PDF ↗ |
| K890854 | EIA READER MODEL EL301 | Bio-Tek Instruments, Inc. | 1989-03-16 | Traditional | PDF ↗ |
| K890502 | MICROLITE TUBE LUMINOMETER #011-902-0000 | Dynatech Laboratories, Inc. | 1989-02-27 | Traditional | PDF ↗ |
| K884782 | MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000) | Dynatech Laboratories, Inc. | 1989-02-17 | Traditional | PDF ↗ |
| K884864 | PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO | The Perkin-Elmer Corp. | 1989-02-10 | Traditional | PDF ↗ |
| K884124 | AUTOMATED EIA READER MODEL EL311 | Bio-Tek Instruments, Inc. | 1989-01-03 | Traditional | PDF ↗ |
| K883646 | BEHRING TURBITIMER | Behring Diagnostics, Inc. | 1988-10-31 | Traditional | PDF ↗ |
| K883435 | NOVASPEC II SPECTROPHOTOMETER | Pharmacia, Inc. | 1988-10-13 | Traditional | PDF ↗ |
| K883302 | EMAX PRECISION MICROPLATE READER | Molecular Devices Corp. | 1988-09-13 | Traditional | PDF ↗ |
| K882938 | STAT FAX(TM) | Awareness Technology, Inc. | 1988-09-09 | Traditional | PDF ↗ |
Product code JJQ · Class I · Clinical Chemistry. Data: openFDA.