Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2320](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2320) → JJJ — Counter (Beta, Gamma) For Clinical Use # JJJ · Counter (Beta, Gamma) For Clinical Use _Clinical Chemistry · 21 CFR 862.2320 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ ## Overview - **Product Code:** JJJ - **Device Name:** Counter (Beta, Gamma) For Clinical Use - **Regulation:** [21 CFR 862.2320](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2320) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders. ## 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 the limitations in § 862.9. ## Recent Cleared Devices (20 of 63) Showing 20 most recent of 63 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K962762](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K962762.md) | SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR | Biotraces, Inc. | Aug 16, 1996 | SESE | | [K946387](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K946387.md) | CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER | Capintec, Inc. | Mar 30, 1995 | SESE | | [K920559](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K920559.md) | ABBOTT VERTEX ANALYZER | Abbott Laboratories | Mar 19, 1992 | SESE | | [K900087](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K900087.md) | GENESYS 6000 GAMMA COUNTER | Laboratory Technologies, Inc. | Jul 19, 1990 | SESE | | [K896202](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K896202.md) | MATRIX(TM)-96 | Canberra Industries, Inc. | Jan 2, 1990 | SESE | | [K894902](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K894902.md) | SOURCERER | Oakfield Instruments, Ltd. | Oct 17, 1989 | SESE | | [K884091](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K884091.md) | SOURCERER | John Caunt Scientific , Ltd. | Feb 2, 1989 | SESE | | [K884269](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K884269.md) | SAMPLE IDENTIFICATION STATION MODEL 38010 | Icn Micromedic Systems | Jan 9, 1989 | SESE | | [K874094](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K874094.md) | 1205 BETAPLATE LIQUID SCINTILLATION COUNTER | Lkb Instruments, Inc. | Nov 4, 1987 | SESE | | [K872430](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K872430.md) | ISO-DATA 500 SERIES GAMMA COUNTER | Iso-Data, Inc. | Aug 21, 1987 | SESE | | [K872429](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K872429.md) | ISO-DATA 100 SERIES GAMMA COUNTER | Iso-Data, Inc. | Aug 21, 1987 | SESE | | [K870115](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K870115.md) | BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS | Berthold Analytical Instruments, Inc. | Mar 31, 1987 | SESE | | [K862206](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K862206.md) | TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER | Micromedic Systems | Aug 4, 1986 | SESE | | [K851164](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K851164.md) | DENTOCULT CULTURE-PADDLE | Orion Corp. | Oct 29, 1985 | SESE | | [K851689](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K851689.md) | GENESYS GAMMA COUNTER | Laboratory Technologies, Inc. | Aug 7, 1985 | SESE | | [K852434](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K852434.md) | 1208 BETACORD AND 1208 BETCORD M | Lkb Instruments, Inc. | Aug 2, 1985 | SESE | | [K842902](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K842902.md) | MICROSTAT GAMMA COUNTER | Micromedic Systems | Aug 9, 1984 | SESE | | [K841352](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K841352.md) | ND1200 RIA COUNTER | Nuclear Data, Inc. | May 2, 1984 | SESE | | [K834508](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K834508.md) | CORNING 4000 MULTI-WELL GAMMA COUNTER | Corning Medical & Scientific | Mar 16, 1984 | SESE | | [K832734](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K832734.md) | KEMTEK 400 RIA GAMMA COUNTER | Kemble Instruments, Inc. | Oct 14, 1983 | SESE | ## Top Applicants - Beckman Instruments, Inc. — 7 clearances - Kemble Instruments, Inc. — 6 clearances - Lkb Instruments, Inc. — 5 clearances - Abbott Laboratories — 4 clearances - Micromedic Systems — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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