FDA Product Code
FDA Product Code JJG — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2140
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972409 | AG CHEMISTRY ANALYZER SYSTEM | Landmark Scientific, Inc. | 1997-08-28 | Traditional | PDF ↗ |
| K942782 | PICCOLO(TM) | Abaxis, Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K934592 | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR | Abaxis, Inc. | 1994-04-06 | Traditional | PDF ↗ |
| K920942 | OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER | Olympus Corp. | 1992-06-10 | Traditional | PDF ↗ |
| K910222 | COBAS ALPHA | Roche Diagnostic Systems, Inc. | 1991-02-27 | Traditional | PDF ↗ |
| K903626 | BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA | Beckman Instruments, Inc. | 1990-10-15 | Traditional | PDF ↗ |
| K893854 | COBAS FARA II CENTRIFUGAL ANALYZER | Roche Diagnostic Systems, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K893641 | COBAS FARA CENTRIFUGAL ANALYZER | Roche Diagnostic Systems, Inc. | 1989-07-20 | Traditional | PDF ↗ |
| K885203 | TECHNICON DAX(TM) SYSTEM | Technicon Instruments Corp. | 1989-03-28 | Traditional | PDF ↗ |
| K871973 | IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. | Instrumentation Laboratory CO | 1987-06-11 | Traditional | PDF ↗ |
| K871838 | BIOMEK 1000C AUTOMATED LABORATORY WORK STATION | Beckman Instruments, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K854523 | ANALYST PHYSICIAN'S OFFICE PROFILER | E.I. Dupont DE Nemours & Co., Inc. | 1986-01-08 | Traditional | PDF ↗ |
| K854055 | I.C.L.S. COMPULYZER | Integrated Computerized Laboratory Systems, Inc. | 1985-11-19 | Traditional | PDF ↗ |
| K851619 | GEN PROFILER SYSTEM | Electro-Cucleonics, Inc. | 1985-05-14 | Traditional | PDF ↗ |
| K843914 | COBAS FLUORESCENCE POLARIZATION MODULE | Roche Diagnostic Systems, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K842522 | PDA SYSTEM | Abbott Laboratories | 1984-08-02 | Traditional | PDF ↗ |
| K840231 | DISPOSABLE CUVETTE ARRAY | Consumable Lab Supplies | 1984-03-22 | Traditional | PDF ↗ |
| K832716 | ENCORE CHEMISTRY ANALYZER | Baker Instructions Corp. | 1983-10-04 | Traditional | PDF ↗ |
| K831569 | REAGENT CUPS | American Scientific Products | 1983-06-30 | Traditional | PDF ↗ |
| K831571 | ROTOR | American Scientific Products | 1983-06-30 | Traditional | PDF ↗ |
| K830641 | ENCORE CHEMISTRY ANALYZER | Baker Instructions Corp. | 1983-04-05 | Traditional | PDF ↗ |
| K811525 | FLEXIGRAM AUTO LOADER SYSTEM | Electro-Nucleonics Laboratories, Inc. | 1981-06-18 | Traditional | PDF ↗ |
| K801139 | CENTRIFICHEM SYSTEM 500 ANALYZER | Union Carbide Corp. | 1980-06-09 | Traditional | PDF ↗ |
| K801026 | IL MODEL 773 FLUORESCENCE LIGHT SCATTER | Instrumentation Laboratory CO | 1980-05-28 | Traditional | PDF ↗ |
| K792671 | COBAS-BIO CENTRIFUGAL ANALYZER | Hoffmann-La Roche, Inc. | 1980-01-17 | Traditional | PDF ↗ |
| K791180 | CENTRIFICHEM SYSTEM 500 | Union Carbide Corp. | 1979-08-10 | Traditional | PDF ↗ |
| K790550 | CENTRIA SYSTEM | Union Carbide Corp. | 1979-05-07 | Traditional | PDF ↗ |
| K790278 | ANALYZER, CENTRIFUCHEM SYSTEM 400 | Union Carbide Corp. | 1979-04-04 | Traditional | PDF ↗ |
| K781900 | ANALYZER, AUTOMED CENTRIFUGAL | Autogenic Systems | 1978-12-20 | Traditional | PDF ↗ |
| K771813 | CENTRIFICHEM SYS 400 ANALYZER | Clinical Diagnostics, Inc. | 1977-10-25 | Traditional | PDF ↗ |
Product code JJG · Class I · Clinical Chemistry. Data: openFDA.