Product Code: JJJ FDA class 1 21 CFR 862.2320

Counter (Beta, Gamma) For Clinical Use

Clinical Chemistry

This device is a beta and gamma radiation counter used in clinical laboratory settings to quantify radioactive isotopes in patient specimens or reagents, supporting radioimmunoassay and other radiometric testing procedures. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket notification. The product code is JJJ, regulated under 21 CFR 862.2320, and assigned to the Clinical Chemistry medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: JJJ
Device Class: FDA class 1
Regulation Number: 862.2320
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 63 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K962762	SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR	Aug 16, 1996	Substantially Equivalent	Biotraces, Inc.
K946387	CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER	Mar 30, 1995	Substantially Equivalent	Capintec, Inc.
K920559	ABBOTT VERTEX ANALYZER	Mar 19, 1992	Substantially Equivalent	Abbott Laboratories
K900087	GENESYS 6000 GAMMA COUNTER	Jul 19, 1990	Substantially Equivalent	Laboratory Technologies, Inc.
K896202	MATRIX(TM)-96	Jan 02, 1990	Substantially Equivalent	Canberra Industries, Inc.
K894902	SOURCERER	Oct 17, 1989	Substantially Equivalent	Oakfield Instruments, Ltd.
K884091	SOURCERER	Feb 02, 1989	Substantially Equivalent	John Caunt Scientific , Ltd.
K884269	SAMPLE IDENTIFICATION STATION MODEL 38010	Jan 09, 1989	Substantially Equivalent	Icn Micromedic Systems
K874094	1205 BETAPLATE LIQUID SCINTILLATION COUNTER	Nov 04, 1987	Substantially Equivalent	Lkb Instruments, Inc.
K872430	ISO-DATA 500 SERIES GAMMA COUNTER	Aug 21, 1987	Substantially Equivalent	Iso-Data, Inc.
K872429	ISO-DATA 100 SERIES GAMMA COUNTER	Aug 21, 1987	Substantially Equivalent	Iso-Data, Inc.
K870115	BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS	Mar 31, 1987	Substantially Equivalent	Berthold Analytical Instruments, Inc.
K862206	TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER	Aug 04, 1986	Substantially Equivalent	Micromedic Systems
K851164	DENTOCULT CULTURE-PADDLE	Oct 29, 1985	Substantially Equivalent	Orion Corp.
K851689	GENESYS GAMMA COUNTER	Aug 07, 1985	Substantially Equivalent	Laboratory Technologies, Inc.
K852434	1208 BETACORD AND 1208 BETCORD M	Aug 02, 1985	Substantially Equivalent	Lkb Instruments, Inc.
K842902	MICROSTAT GAMMA COUNTER	Aug 09, 1984	Substantially Equivalent	Micromedic Systems
K841352	ND1200 RIA COUNTER	May 02, 1984	Substantially Equivalent	Nuclear Data, Inc.
K834508	CORNING 4000 MULTI-WELL GAMMA COUNTER	Mar 16, 1984	Substantially Equivalent	Corning Medical & Scientific
K832734	KEMTEK 400 RIA GAMMA COUNTER	Oct 14, 1983	Substantially Equivalent	Kemble Instruments, Inc.
K832736	KEMTEK 104 RIA GAMMA COUNTER	Sep 29, 1983	Substantially Equivalent	Kemble Instruments, Inc.
K832735	KEMTEK 103 RIA GAMMA COUNTER	Sep 29, 1983	Substantially Equivalent	Kemble Instruments, Inc.
K832210	GAMMA PHOTON GAMMA COUNTER	Aug 24, 1983	Substantially Equivalent	Medical & Scientific Designs, Inc.
K832209	KINETI COUNT 24 GAMMA COUNTER	Aug 24, 1983	Substantially Equivalent	Medical & Scientific Designs, Inc.
K832002	NML-5010/5020 MULTI-DETECTOR SYSTEM	Aug 08, 1983	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K830751	KEMTEK 102	Apr 06, 1983	Substantially Equivalent	Kemble Instruments, Inc.
K830365	KINETI COUNT 48 IMMUNOASSAY SYSTEM	Mar 10, 1983	Substantially Equivalent	Medical & Scientific Designs, Inc.
K823240	CAP-RIA 16	Dec 03, 1982	Substantially Equivalent	Capintec, Inc.
K822293	IMMU-COUNT 404	Aug 24, 1982	Substantially Equivalent	Kemble Instruments, Inc.
K821892	PHILLIPS RADIATION MEASURING INSTRUMENT	Jul 13, 1982	Substantially Equivalent	Long Island Scientific
K821494	RIA STAT 16	Jun 03, 1982	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K820376	MICROMEDIC SYSTEMS ISOFLEX	Mar 16, 1982	Substantially Equivalent	Micromedic Systems
K820137	IMMU-COUNT	Feb 05, 1982	Substantially Equivalent	Kemble Instruments, Inc.
K813472	LS 5800 SERIES LIQUID SCINTILLATION	Dec 29, 1981	Substantially Equivalent	Beckman Instruments, Inc.
K810345	LIQUID SCINTILLATION SPECTROPHOTOMETER	Feb 25, 1981	Substantially Equivalent	Beckman Instruments, Inc.
K802578	PACE-4-AUTOMATIC RIA GAMMA-COUTER	Dec 18, 1980	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K801264	NUCLEAR ENTERPRISES 1600/GAMMA COUNTER	Jun 26, 1980	Substantially Equivalent	Nuclear Ent. , Ltd.
K801263	NUCLEAR ENTERPRISES 1612 MULTI-WELL	Jun 20, 1980	Substantially Equivalent	Nuclear Ent. , Ltd.
K801245	ATOMLIGHT (LIQUID SCINTILLATION SOLUTION	Jun 20, 1980	Substantially Equivalent	New England Nuclear
K800601	HYDRAGAMMA 16	Apr 10, 1980	Substantially Equivalent	Innotron of Oregon, Inc.
K800388	NML 5000 AUTO. GAMMA SCINT. COUNTER	Mar 12, 1980	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K790961	LIQUID SCINTILLATION COUNTER	Jun 28, 1979	Substantially Equivalent	Nuclear Ent. , Ltd.
K790905	NUCLEAR SAMPLE READER	Jun 15, 1979	Substantially Equivalent	Abbott Laboratories
K780790	IDI 200 GAMMA COUNTER	Jun 22, 1978	Substantially Equivalent	Iso-Data, Inc.
K780341	SCINTILLATION, LIQUID, RACKBETA	May 26, 1978	Substantially Equivalent	Lkb Instruments, Inc.
K780344	GAMMA COUNTER	Apr 12, 1978	Substantially Equivalent	Lkb Instruments, Inc.
K771614	AUTO. WELL TYPE GAMMA COUNTERS	Apr 12, 1978	Substantially Equivalent	Actus, Inc.
K771613	WELL TYPE GAMMA COUNTER	Apr 10, 1978	Substantially Equivalent	Actus, Inc.
K771612	WELL TYPE GAMMA COUNTER	Apr 10, 1978	Substantially Equivalent	Actus, Inc.
K780383	COUNTER, RADIOASSAY, AUTO., MICROMEDIC	Mar 22, 1978	Substantially Equivalent	Micromedic Systems
K780179	LIQUID SCINTILLATION COUNTER	Feb 23, 1978	Substantially Equivalent	Roche Medical Electronics, Inc.
K772099	PRINTER	Jan 26, 1978	Substantially Equivalent	Miles Laboratories, Inc.
K771369	LIQ. SCINTILLATION SPECTROPHOTOMETEO	Sep 14, 1977	Substantially Equivalent	Beckman Instruments, Inc.
K771129	AUTO-LOGIC II SYSTEM	Aug 04, 1977	Substantially Equivalent	Abbott Laboratories
K771180	GAMMA GOUNTING SYS., AUTO, MODEL 1400	Aug 03, 1977	Substantially Equivalent	G.D. Searle and Co.
K770740	RADIOASSAY TUBES & RADIOASSAY TUBE CAPS	Jun 22, 1977	Substantially Equivalent	G.D. Searle and Co.
K770572	DP-5000 DATA REDUCTION SYSTEM	Apr 15, 1977	Substantially Equivalent	Beckman Instruments, Inc.
K770088	GAMMA 4000 SCINTILLATION COUNTER	Feb 14, 1977	Substantially Equivalent	Beckman Instruments, Inc.
K761214	WELL COUNTERS, LOGIC II (200 SERIES)	Dec 16, 1976	Substantially Equivalent	Abbott Laboratories
K760900	GAMMA SCINTILLATION COUNTER	Nov 16, 1976	Substantially Equivalent	Beckman Instruments, Inc.
K760424	LIQUID SCINTILLATION COUNTER	Nov 02, 1976	Substantially Equivalent	Beckman Instruments, Inc.
K760828	BLASTOMYCES YEAST ANTIGEN	Nov 01, 1976	Substantially Equivalent	I M, Inc.
K760470	COUNTER, RACK GAMMA (#1270)	Nov 01, 1976	Substantially Equivalent	Lkb Instruments, Inc.