Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2140](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2140) → JJG — Analyzer, Chemistry, Centrifugal, For Clinical Use # JJG · Analyzer, Chemistry, Centrifugal, For Clinical Use _Clinical Chemistry · 21 CFR 862.2140 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG ## Overview - **Product Code:** JJG - **Device Name:** Analyzer, Chemistry, Centrifugal, For Clinical Use - **Regulation:** [21 CFR 862.2140](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2140) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## 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](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K972409.md) | AG CHEMISTRY ANALYZER SYSTEM | Landmark Scientific, Inc. | Aug 28, 1997 | SESE | | [K942782](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K942782.md) | PICCOLO(TM) | Abaxis, Inc. | Mar 13, 1995 | SESE | | [K934592](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K934592.md) | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR | Abaxis, Inc. | Apr 6, 1994 | SESE | | [K920942](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K920942.md) | OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER | Olympus Corp. | Jun 10, 1992 | SESE | | [K910222](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K910222.md) | COBAS ALPHA | Roche Diagnostic Systems, Inc. | Feb 27, 1991 | SESE | | [K903626](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K903626.md) | BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA | Beckman Instruments, Inc. | Oct 15, 1990 | SESE | | [K893854](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K893854.md) | COBAS FARA II CENTRIFUGAL ANALYZER | Roche Diagnostic Systems, Inc. | Aug 3, 1989 | SESE | | [K893641](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K893641.md) | COBAS FARA CENTRIFUGAL ANALYZER | Roche Diagnostic Systems, Inc. | Jul 20, 1989 | SESE | | [K885203](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K885203.md) | TECHNICON DAX(TM) SYSTEM | Technicon Instruments Corp. | Mar 28, 1989 | SESE | | [K871973](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K871973.md) | IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. | Instrumentation Laboratory CO | Jun 11, 1987 | SESE | | [K871838](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K871838.md) | BIOMEK 1000C AUTOMATED LABORATORY WORK STATION | Beckman Instruments, Inc. | May 26, 1987 | SESE | | [K854523](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K854523.md) | ANALYST PHYSICIAN'S OFFICE PROFILER | E.I. Dupont DE Nemours & Co., Inc. | Jan 8, 1986 | SESE | | [K854055](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K854055.md) | I.C.L.S. COMPULYZER | Integrated Computerized Laboratory Systems, Inc. | Nov 19, 1985 | SESE | | [K851619](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K851619.md) | GEN PROFILER SYSTEM | Electro-Cucleonics, Inc. | May 14, 1985 | SESE | | [K843914](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K843914.md) | COBAS FLUORESCENCE POLARIZATION MODULE | Roche Diagnostic Systems, Inc. | Nov 27, 1984 | SESE | | [K842522](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K842522.md) | PDA SYSTEM | Abbott Laboratories | Aug 2, 1984 | SESE | | [K840231](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K840231.md) | DISPOSABLE CUVETTE ARRAY | Consumable Lab Supplies | Mar 22, 1984 | SESE | | [K832716](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K832716.md) | ENCORE CHEMISTRY ANALYZER | Baker Instructions Corp. | Oct 4, 1983 | SESE | | [K831571](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K831571.md) | ROTOR | American Scientific Products | Jun 30, 1983 | SESE | | [K831569](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K831569.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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