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 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K882608 | LAD MODEL 633 LUMINOMETER | Los Alamos Diagnostics | 1988-08-29 | Traditional | PDF ↗ |
| K882095 | MODIFICATION OF BEHRING RAPIMAT II/T | Behring Diagnostics, Inc. | 1988-08-02 | Traditional | PDF ↗ |
| K881458 | ASTROSCAN 2100 MICROTITER PLATE READER | Astroscan , Ltd. | 1988-06-29 | Traditional | PDF ↗ |
| K881797 | EASY WASHER II MICROPLATE WASHER | Slt Labinstruments, Inc. | 1988-06-15 | Traditional | PDF ↗ |
| K881877 | COBAS EIA(TM) PHOTOMETER | Roche Diagnostic Systems, Inc. | 1988-06-10 | Traditional | PDF ↗ |
| K881803 | UVMAX KINETIC MICROPLATE READER | Molecular Devices Corp. | 1988-05-31 | Traditional | PDF ↗ |
| K873893 | LUMICON | Hamilton Co. | 1988-01-05 | Traditional | PDF ↗ |
| K874262 | LAD MODEL 735 LUMINOMETER | Los Alamos Diagnostics | 1987-11-27 | Traditional | PDF ↗ |
| K873384 | CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA | Helena Laboratories | 1987-11-20 | Traditional | PDF ↗ |
| K873451 | PROJECT 300 MICROASSAY BP-12, EIA MINILAB | Awareness Technology, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K874244 | DYNATECH MR 300 MANUAL MICROELISA | Dynatech Laboratories, Inc. | 1987-11-03 | Traditional | PDF ↗ |
| K873678 | SPECTROPHOTOMETER (MICROASSAY PLATE READERS) | Slt Labinstruments, Inc. | 1987-09-29 | Traditional | PDF ↗ |
| K873638 | MICRO-CHEM ANALYZER | Ocean Scientific, Inc. | 1987-09-29 | Traditional | PDF ↗ |
| K873583 | AUTO-EIA | Labsystems, Inc. | 1987-09-22 | Traditional | PDF ↗ |
| K872749 | SPECTROPHOTOMETERS MODELS:ABC+,ABC,S 500, S 1000 | Secomam Co. | 1987-09-16 | Traditional | PDF ↗ |
| K873138 | MICRO-READER II | Hyperion, Inc. | 1987-09-14 | Traditional | PDF ↗ |
| K873408 | MODEL 690 SPECTROPHOTOMETER | Abbott Diagnostics | 1987-09-08 | Traditional | PDF ↗ |
| K872219 | GEN-PROBE (R) LUMINOMETER - LEADER (TM) | Gen-Probe, Inc. | 1987-08-21 | Traditional | PDF ↗ |
| K872324 | LB 9502 - CLINILUMAT, LB 952 - AUTO-CLINILUMAT | Berthold Analytical Instruments, Inc. | 1987-08-19 | Traditional | PDF ↗ |
| K871874 | CIBA CORNING MAGIC LITE ANALYZER II | Ciba Corning Diagnostics Corp. | 1987-05-26 | Traditional | PDF ↗ |
| K871307 | SYVA Q-SPEC PHOTOMETER | Syva Co. | 1987-05-26 | Traditional | PDF ↗ |
| K871415 | MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) | Dynatech Laboratories, Inc. | 1987-04-22 | Traditional | PDF ↗ |
| K864542 | ARTEL DIFFERENTIAL PHOTOMETER | Artel, Inc. | 1987-02-06 | Traditional | PDF ↗ |
| K864451 | UV VISIBLE SPECTROPHOTOMETERS | Trans-National Trade Development Corp. | 1987-02-06 | Traditional | PDF ↗ |
| K864566 | ADX(TM) ANALYZER | Abbott Laboratories | 1987-02-04 | Traditional | PDF ↗ |
| K864201 | LAD MODEL 535 LUMINOMETER | Los Alamos Diagnostics | 1987-01-13 | Traditional | PDF ↗ |
| K863959 | OHMEDA 6000 MULTI-GAS MONITOR | Ohmeda Medical | 1987-01-12 | Traditional | PDF ↗ |
| K864285 | TERUMO OVATION SPECTROPHOTOMETER | Terumo Medical Corp. | 1987-01-09 | Traditional | PDF ↗ |
| K864634 | AP1 COLORIMETER | Awareness Technology, Inc. | 1986-12-31 | Traditional | PDF ↗ |
| K864319 | TDX(R) II ANALYZER | Abbott Laboratories | 1986-12-16 | Traditional | PDF ↗ |
| K864060 | MICRO-READER | Hyperion, Inc. | 1986-11-28 | Traditional | PDF ↗ |
| K863802 | VMAX KINETIC MICROPLATE READER | Molecular Devices Corp. | 1986-11-05 | Traditional | PDF ↗ |
| K863566 | GSC 1000 | Genetic Systems Corp. | 1986-10-16 | Traditional | PDF ↗ |
| K861263 | BEHRING RAPIMAT II | Behring Diagnostics, Inc. | 1986-10-03 | Traditional | PDF ↗ |
| K862908 | AKERSCAN COLORIMETRIC ANALYZER | Akers Medical Technologies | 1986-09-15 | Traditional | PDF ↗ |
| K862999 | ULTRASCAN CLINICAL ANALYZER | Specialty Medical Industries, Inc. | 1986-09-15 | Traditional | PDF ↗ |
| K861897 | UNISKAN II | Flow Laboratories, Inc. | 1986-07-01 | Traditional | PDF ↗ |
| K860720 | BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) | Biotrack, Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K861617 | THE PARTNER SPECTROPHOTOMETER | Pharmacia, Inc. | 1986-05-19 | Traditional | PDF ↗ |
| K860987 | MINI-CHEM ANALYZER | Ocean Scientific, Inc. | 1986-05-05 | Traditional | PDF ↗ |
| K861223 | THE JR. PARTNER SPECTROPHOTOMETER | Pharmacia, Inc. | 1986-05-05 | Traditional | PDF ↗ |
| K861194 | ULTROSPEC K KINETICS SPECTROPHOTOMETER | Lkb Instruments, Inc. | 1986-04-24 | Traditional | PDF ↗ |
| K855108 | RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR | Biomaterials International, Inc. | 1986-02-21 | Traditional | PDF ↗ |
| K854679 | PHOTIC-100 SPECTROPHOTOMETER | Future Impex Corp. | 1986-02-20 | Traditional | PDF ↗ |
| K855149 | COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER | Hyperion, Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K854210 | TERUMO SENSIBEAD EIA COLORIMETER | Terumo Medical Corp. | 1985-12-05 | Traditional | PDF ↗ |
| K854540 | RAICHEM/K.E | Reagents Applications, Inc. | 1985-11-26 | Traditional | PDF ↗ |
| K854303 | MR 700 MICROPLATE READER 012-700-1000 | Dynatech Laboratories, Inc. | 1985-11-19 | Traditional | PDF ↗ |
| K853284 | MYREADER 7 | Scientific Sales Intl., Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K852411 | MR 650 MICROPLATE READER(CAT. NO. 011-973-0500) | Dynatech Laboratories, Inc. | 1985-09-30 | Traditional | PDF ↗ |
| K853453 | BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER | Bio Automed Systems, Inc. | 1985-09-30 | Traditional | PDF ↗ |
| K852538 | LKB 4057 ULTROSPEC II E | Lkb Instruments, Inc. | 1985-09-30 | Traditional | PDF ↗ |
| K852481 | UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM | Em Diagnostic Systems, Inc. | 1985-08-21 | Traditional | PDF ↗ |
| K844894 | PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES | Slt Labinstruments, Inc. | 1985-06-25 | Traditional | PDF ↗ |
| K852047 | SC-360 SPECTROPHOTOMETER | Pharmacia, Inc. | 1985-05-31 | Traditional | PDF ↗ |
| K851572 | NOVASPEC VISIBLE SPECTROPHOTOMETER | Lkb Instruments, Inc. | 1985-05-20 | Traditional | PDF ↗ |
| K850995 | SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P | Awareness Technology, Inc. | 1985-05-10 | Traditional | PDF ↗ |
| K850994 | SPECTRA 1 FILTER PHOTOMETER | Awareness Technology, Inc. | 1985-05-10 | Traditional | PDF ↗ |
| K850993 | SMART ALEX II MULTI-FILTER PHOTOMETER | Awareness Technology, Inc. | 1985-05-07 | Traditional | PDF ↗ |
| K851098 | BEHRING VECTOR PHOTOMETER | Behring Diagnostics, Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K850392 | INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS | Clinical Data, Inc. | 1985-04-12 | Traditional | PDF ↗ |
| K844419 | TITERTEK MULTISKAN MSS/340 | Flow Laboratories, Inc. | 1985-03-21 | Traditional | PDF ↗ |
| K844567 | TITERTEK TWINREADER 78-630-00 | Flow Laboratories, Inc. | 1985-03-21 | Traditional | PDF ↗ |
| K844418 | TITERTEK MULTISKAN MCC | Flow Laboratories, Inc. | 1985-03-21 | Traditional | PDF ↗ |
| K850767 | SPECTRONIC 2000 SPECTROPHOTOMETER | Bausch & Lomb, Inc. | 1985-03-14 | Traditional | PDF ↗ |
| K850709 | SPECTRONIC 501 & 601 - CLINICAL SPECTROPHOTOMETER | Bausch & Lomb, Inc. | 1985-03-12 | Traditional | PDF ↗ |
| K850348 | UROTRON RL9 | Boehringer Mannheim Corp. | 1985-03-12 | Traditional | PDF ↗ |
| K850708 | SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER | Bausch & Lomb, Inc. | 1985-03-11 | Traditional | PDF ↗ |
| K842474 | GLUCOCHEK III | Larken Industries, Inc. | 1985-02-12 | Traditional | PDF ↗ |
| K843668 | PHOTOMETER 90IYS | Institute Virion , Ltd. | 1984-10-30 | Traditional | PDF ↗ |
| K841648 | DIAGEM DIGITAL BLOOD GLUCOSE MONITOR | Forward Medical Supplies | 1984-10-11 | Traditional | PDF ↗ |
| K843460 | ULTRAVIOLET-VISIBLE SPECTROPHOTOMETER | Varian Assoc., Inc. | 1984-09-26 | Traditional | PDF ↗ |
| K842947 | MICROBIOLOGICAL TRAY READER-MANUAL | American Micro Scan | 1984-09-14 | Traditional | PDF ↗ |
| K842770 | MACBETH COLOR EIAD 100/100PC | Macbeth | 1984-09-14 | Traditional | PDF ↗ |
| K843296 | ELVI 675 DIGITRON | Logos Scientific, Inc. | 1984-09-13 | Traditional | PDF ↗ |
| K842311 | CHEMISTRY ANALYZER, GEN. PURPOSE | Hml Inc/Biotechnology Transfer | 1984-07-25 | Traditional | PDF ↗ |
| K842085 | AUTOMATED EIA MICROPLATE READER EL310 | Bio-Tek Instruments, Inc. | 1984-06-11 | Traditional | PDF ↗ |
| K841557 | ORTHO MICROWELL READER | Ortho Diagnostic Systems, Inc. | 1984-05-22 | Traditional | PDF ↗ |
| K841214 | LABSYSTEMS UNISKAN | Labsystems, Inc. | 1984-04-13 | Traditional | PDF ↗ |
| K840340 | CHEM-STAT ANALYZER | Ocean Scientific, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K834489 | ULTROSPEC W/APPLE II -4050- | Lkb Instruments, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K834099 | BLOOD GLUCOSE MONITOR | Healthdyne, Inc. | 1984-02-03 | Traditional | PDF ↗ |
| K834150 | STRIP SPLITTER II -HALF WIDTH CARRIER | Larken Industries, Inc. | 1984-01-11 | Traditional | PDF ↗ |
| K832531 | PHOTOMETER LP 300 | Dr. Bruno Lange GmbH | 1983-12-12 | Traditional | PDF ↗ |
| K832397 | HYBRITECH 405-500 NM FILTER MODULE | Hybritech, Inc. | 1983-08-31 | Traditional | PDF ↗ |
| K832364 | PHOTON IMMUNOASSAY ANALYZER | Hybritech, Inc. | 1983-08-26 | Traditional | PDF ↗ |
| K832206 | SPECTROPHOTOMETER #390 | Abbott Diagnostics | 1983-08-24 | Traditional | PDF ↗ |
| K831866 | MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC | Varian Assoc., Inc. | 1983-07-28 | Traditional | PDF ↗ |
| K830569 | CYNOX I HEMOGLOBINOMETER | Buffalo Medical Specialties Mfg., Inc. | 1983-04-08 | Traditional | PDF ↗ |
| K823512 | MR 600 MICROPLATE READER | Laboratory and Medical Products Group | 1983-03-01 | Traditional | PDF ↗ |
| K823590 | MANUALISA MICROTITRATION PLATE READER | Ortho Diagnostic Systems, Inc. | 1983-02-28 | Traditional | PDF ↗ |
| K830101 | COLORIMETERS SERIES ONE 12 | Innotron of Oregon, Inc. | 1983-01-28 | Traditional | PDF ↗ |
| K823720 | SPECTROPHOTOMETER | Macomb Chemical Co. | 1983-01-07 | Traditional | PDF ↗ |
| K823266 | POSITIVE I.D. SYSTEM | Abbott Laboratories | 1982-12-15 | Traditional | PDF ↗ |
| K822800 | PICOLITE | United Technologies Packard | 1982-10-27 | Traditional | PDF ↗ |
| K822720 | MODEL 340 SPECTROPHOTOMETER | Abbott Diagnostics | 1982-10-08 | Traditional | PDF ↗ |
| K822050 | STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO | Helena Laboratories | 1982-08-27 | Traditional | PDF ↗ |
| K821439 | MR 600 MICROPLATE READER | Dynatech Corp. | 1982-06-01 | Traditional | PDF ↗ |
| K821561 | VERSACHEM ANALYZER | Emd Chemicals, Inc. | 1982-06-01 | Traditional | PDF ↗ |
| K813563 | PHADEZYM ANALYZER | Pharmacia, Inc. | 1982-03-22 | Traditional | PDF ↗ |
Product code JJQ · Class I · Clinical Chemistry. Data: openFDA.