JJG — Analyzer, Chemistry, Centrifugal, For Clinical Use Class I
FDA Device Classification
Classification Details
- Product Code
- JJG
- Device Class
- Class I
- Regulation Number
- 862.2140
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K972409 | landmark scientific | AG CHEMISTRY ANALYZER SYSTEM | August 28, 1997 |
| K942782 | abaxis | PICCOLO(TM) | March 13, 1995 |
| K934592 | abaxis | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR | April 6, 1994 |
| K920942 | olympus | OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER | June 10, 1992 |
| K910222 | roche diagnostic systems | COBAS ALPHA | February 27, 1991 |
| K903626 | beckman instruments | BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA | October 15, 1990 |
| K893854 | roche diagnostic systems | COBAS FARA II CENTRIFUGAL ANALYZER | August 3, 1989 |
| K893641 | roche diagnostic systems | COBAS FARA CENTRIFUGAL ANALYZER | July 20, 1989 |
| K885203 | technicon instruments | TECHNICON DAX(TM) SYSTEM | March 28, 1989 |
| K871973 | instrumentation laboratory | IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. | June 11, 1987 |
| K871838 | beckman instruments | BIOMEK 1000C AUTOMATED LABORATORY WORK STATION | May 26, 1987 |
| K854523 | e.i. dupont de nemours and co | ANALYST PHYSICIAN'S OFFICE PROFILER | January 8, 1986 |
| K854055 | integrated computerized laboratory systems | I.C.L.S. COMPULYZER | November 19, 1985 |
| K851619 | electro-cucleonics | GEN PROFILER SYSTEM | May 14, 1985 |
| K843914 | roche diagnostic systems | COBAS FLUORESCENCE POLARIZATION MODULE | November 27, 1984 |
| K842522 | abbott laboratories | PDA SYSTEM | August 2, 1984 |
| K840231 | consumable lab supplies | DISPOSABLE CUVETTE ARRAY | March 22, 1984 |
| K832716 | baker instructions | ENCORE CHEMISTRY ANALYZER | October 4, 1983 |
| K831571 | american scientific products | ROTOR | June 30, 1983 |
| K831569 | american scientific products | REAGENT CUPS | June 30, 1983 |