JJG · Analyzer, Chemistry, Centrifugal, For Clinical Use
Clinical Chemistry · 21 CFR 862.2140 · Class 1
Overview
| Product Code | JJG |
|---|---|
| Device Name | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Regulation | 21 CFR 862.2140 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and spectrophotometrically measure concentrations of the sample constituents. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972409 | AG CHEMISTRY ANALYZER SYSTEM | Landmark Scientific, Inc. | Aug 28, 1997 | SESE |
| K942782 | PICCOLO(TM) | Abaxis, Inc. | Mar 13, 1995 | SESE |
| K934592 | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR | Abaxis, Inc. | Apr 6, 1994 | SESE |
| K920942 | OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER | Olympus Corp. | Jun 10, 1992 | SESE |
| K910222 | COBAS ALPHA | Roche Diagnostic Systems, Inc. | Feb 27, 1991 | SESE |
| K903626 | BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA | Beckman Instruments, Inc. | Oct 15, 1990 | SESE |
| K893854 | COBAS FARA II CENTRIFUGAL ANALYZER | Roche Diagnostic Systems, Inc. | Aug 3, 1989 | SESE |
| K893641 | COBAS FARA CENTRIFUGAL ANALYZER | Roche Diagnostic Systems, Inc. | Jul 20, 1989 | SESE |
| K885203 | TECHNICON DAX(TM) SYSTEM | Technicon Instruments Corp. | Mar 28, 1989 | SESE |
| K871973 | IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. | Instrumentation Laboratory CO | Jun 11, 1987 | SESE |
| K871838 | BIOMEK 1000C AUTOMATED LABORATORY WORK STATION | Beckman Instruments, Inc. | May 26, 1987 | SESE |
| K854523 | ANALYST PHYSICIAN'S OFFICE PROFILER | E.I. Dupont DE Nemours & Co., Inc. | Jan 8, 1986 | SESE |
| K854055 | I.C.L.S. COMPULYZER | Integrated Computerized Laboratory Systems, Inc. | Nov 19, 1985 | SESE |
| K851619 | GEN PROFILER SYSTEM | Electro-Cucleonics, Inc. | May 14, 1985 | SESE |
| K843914 | COBAS FLUORESCENCE POLARIZATION MODULE | Roche Diagnostic Systems, Inc. | Nov 27, 1984 | SESE |
| K842522 | PDA SYSTEM | Abbott Laboratories | Aug 2, 1984 | SESE |
| K840231 | DISPOSABLE CUVETTE ARRAY | Consumable Lab Supplies | Mar 22, 1984 | SESE |
| K832716 | ENCORE CHEMISTRY ANALYZER | Baker Instructions Corp. | Oct 4, 1983 | SESE |
| K831571 | ROTOR | American Scientific Products | Jun 30, 1983 | SESE |
| K831569 | REAGENT CUPS | American Scientific Products | Jun 30, 1983 | SESE |
Top Applicants
- Roche Diagnostic Systems, Inc. — 4 clearances
- Union Carbide Corp. — 4 clearances
- Abaxis, Inc. — 2 clearances
- American Scientific Products — 2 clearances
- Baker Instructions Corp. — 2 clearances
