Product code JJG
- Device name
- Analyzer, Chemistry, Centrifugal, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2140
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972409 | AG CHEMISTRY ANALYZER SYSTEM | Landmark Scientific, Inc. | 1997-08-28 |
| K942782 | PICCOLO(TM) | Abaxis, Inc. | 1995-03-13 |
| K934592 | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR | Abaxis, Inc. | 1994-04-06 |
| K920942 | OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER | Olympus Corp. | 1992-06-10 |
| K910222 | COBAS ALPHA | Roche Diagnostic Systems, Inc. | 1991-02-27 |
| K903626 | BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA | Beckman Instruments, Inc. | 1990-10-15 |
| K893854 | COBAS FARA II CENTRIFUGAL ANALYZER | Roche Diagnostic Systems, Inc. | 1989-08-03 |
| K893641 | COBAS FARA CENTRIFUGAL ANALYZER | Roche Diagnostic Systems, Inc. | 1989-07-20 |
| K885203 | TECHNICON DAX(TM) SYSTEM | Technicon Instruments Corp. | 1989-03-28 |
| K871973 | IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. | Instrumentation Laboratory CO | 1987-06-11 |
| K871838 | BIOMEK 1000C AUTOMATED LABORATORY WORK STATION | Beckman Instruments, Inc. | 1987-05-26 |
| K854523 | ANALYST PHYSICIAN'S OFFICE PROFILER | E.I. Dupont DE Nemours & Co., Inc. | 1986-01-08 |
| K854055 | I.C.L.S. COMPULYZER | Integrated Computerized Laboratory Systems, Inc. | 1985-11-19 |
| K851619 | GEN PROFILER SYSTEM | Electro-Cucleonics, Inc. | 1985-05-14 |
| K843914 | COBAS FLUORESCENCE POLARIZATION MODULE | Roche Diagnostic Systems, Inc. | 1984-11-27 |
| K842522 | PDA SYSTEM | Abbott Laboratories | 1984-08-02 |
| K840231 | DISPOSABLE CUVETTE ARRAY | Consumable Lab Supplies | 1984-03-22 |
| K832716 | ENCORE CHEMISTRY ANALYZER | Baker Instructions Corp. | 1983-10-04 |
| K831571 | ROTOR | American Scientific Products | 1983-06-30 |
| K831569 | REAGENT CUPS | American Scientific Products | 1983-06-30 |
| K830641 | ENCORE CHEMISTRY ANALYZER | Baker Instructions Corp. | 1983-04-05 |
| K811525 | FLEXIGRAM AUTO LOADER SYSTEM | Electro-Nucleonics Laboratories, Inc. | 1981-06-18 |
| K801139 | CENTRIFICHEM SYSTEM 500 ANALYZER | Union Carbide Corp. | 1980-06-09 |
| K801026 | IL MODEL 773 FLUORESCENCE LIGHT SCATTER | Instrumentation Laboratory CO | 1980-05-28 |
| K792671 | COBAS-BIO CENTRIFUGAL ANALYZER | Hoffmann-La Roche, Inc. | 1980-01-17 |
| K791180 | CENTRIFICHEM SYSTEM 500 | Union Carbide Corp. | 1979-08-10 |
| K790550 | CENTRIA SYSTEM | Union Carbide Corp. | 1979-05-07 |
| K790278 | ANALYZER, CENTRIFUCHEM SYSTEM 400 | Union Carbide Corp. | 1979-04-04 |
| K781900 | ANALYZER, AUTOMED CENTRIFUGAL | Autogenic Systems | 1978-12-20 |
| K771813 | CENTRIFICHEM SYS 400 ANALYZER | Clinical Diagnostics, Inc. | 1977-10-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| EABA11001511 | Piccolo Xpress Military Deployment Kit | ABAXIS, INC. | 2017-06-30 |
| EABA110000001 | Piccolo Xpress | ABAXIS, INC. | 2016-09-23 |