Atlas FDA

JJJ

63 FDA 510(k) clearances · Product code

42 daysmedian time to decision
125 days90th percentile
63clearances measured

FDA profile

Official device name
Counter (Beta, Gamma) For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2320
Medical specialty
Clinical Chemistry
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RecordFirmDate
SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR (K962762)Biotraces, Inc.1996-08-16
CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER (K946387)Capintec, Inc.1995-03-30
ABBOTT VERTEX ANALYZER (K920559)Abbott Laboratories1992-03-19
GENESYS 6000 GAMMA COUNTER (K900087)Laboratory Technologies, Inc.1990-07-19
MATRIX(TM)-96 (K896202)Canberra Industries, Inc.1990-01-02
SOURCERER (K894902)Oakfield Instruments, Ltd.1989-10-17
SOURCERER (K884091)John Caunt Scientific , Ltd.1989-02-02
SAMPLE IDENTIFICATION STATION MODEL 38010 (K884269)Icn Micromedic Systems1989-01-09
1205 BETAPLATE LIQUID SCINTILLATION COUNTER (K874094)Lkb Instruments, Inc.1987-11-04
ISO-DATA 500 SERIES GAMMA COUNTER (K872430)Iso-Data, Inc.1987-08-21
ISO-DATA 100 SERIES GAMMA COUNTER (K872429)Iso-Data, Inc.1987-08-21
BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS (K870115)Berthold Analytical Instruments, Inc.1987-03-31
TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER (K862206)Micromedic Systems1986-08-04
DENTOCULT CULTURE-PADDLE (K851164)Orion Corp.1985-10-29
GENESYS GAMMA COUNTER (K851689)Laboratory Technologies, Inc.1985-08-07
1208 BETACORD AND 1208 BETCORD M (K852434)Lkb Instruments, Inc.1985-08-02
MICROSTAT GAMMA COUNTER (K842902)Micromedic Systems1984-08-09
ND1200 RIA COUNTER (K841352)Nuclear Data, Inc.1984-05-02
CORNING 4000 MULTI-WELL GAMMA COUNTER (K834508)Corning Medical & Scientific1984-03-16
KEMTEK 400 RIA GAMMA COUNTER (K832734)Kemble Instruments, Inc.1983-10-14
KEMTEK 104 RIA GAMMA COUNTER (K832736)Kemble Instruments, Inc.1983-09-29
KEMTEK 103 RIA GAMMA COUNTER (K832735)Kemble Instruments, Inc.1983-09-29
GAMMA PHOTON GAMMA COUNTER (K832210)Medical & Scientific Designs, Inc.1983-08-24
KINETI COUNT 24 GAMMA COUNTER (K832209)Medical & Scientific Designs, Inc.1983-08-24
NML-5010/5020 MULTI-DETECTOR SYSTEM (K832002)Nuclear Medical Laboratories, Inc.1983-08-08
KEMTEK 102 (K830751)Kemble Instruments, Inc.1983-04-06
KINETI COUNT 48 IMMUNOASSAY SYSTEM (K830365)Medical & Scientific Designs, Inc.1983-03-10
CAP-RIA 16 (K823240)Capintec, Inc.1982-12-03
IMMU-COUNT 404 (K822293)Kemble Instruments, Inc.1982-08-24
PHILLIPS RADIATION MEASURING INSTRUMENT (K821892)Long Island Scientific1982-07-13
RIA STAT 16 (K821494)E. R. Squibb & Sons, Inc.1982-06-03
MICROMEDIC SYSTEMS ISOFLEX (K820376)Micromedic Systems1982-03-16
IMMU-COUNT (K820137)Kemble Instruments, Inc.1982-02-05
LS 5800 SERIES LIQUID SCINTILLATION (K813472)Beckman Instruments, Inc.1981-12-29
LIQUID SCINTILLATION SPECTROPHOTOMETER (K810345)Beckman Instruments, Inc.1981-02-25
PACE-4-AUTOMATIC RIA GAMMA-COUTER (K802578)Philips Medical Systems (Cleveland), Inc.1980-12-18
NUCLEAR ENTERPRISES 1600/GAMMA COUNTER (K801264)Nuclear Ent. , Ltd.1980-06-26
NUCLEAR ENTERPRISES 1612 MULTI-WELL (K801263)Nuclear Ent. , Ltd.1980-06-20
ATOMLIGHT (LIQUID SCINTILLATION SOLUTION (K801245)New England Nuclear1980-06-20
HYDRAGAMMA 16 (K800601)Innotron of Oregon, Inc.1980-04-10
NML 5000 AUTO. GAMMA SCINT. COUNTER (K800388)Nuclear Medical Laboratories, Inc.1980-03-12
LIQUID SCINTILLATION COUNTER (K790961)Nuclear Ent. , Ltd.1979-06-28
NUCLEAR SAMPLE READER (K790905)Abbott Laboratories1979-06-15
IDI 200 GAMMA COUNTER (K780790)Iso-Data, Inc.1978-06-22
SCINTILLATION, LIQUID, RACKBETA (K780341)Lkb Instruments, Inc.1978-05-26
AUTO. WELL TYPE GAMMA COUNTERS (K771614)Actus, Inc.1978-04-12
GAMMA COUNTER (K780344)Lkb Instruments, Inc.1978-04-12
WELL TYPE GAMMA COUNTER (K771612)Actus, Inc.1978-04-10
WELL TYPE GAMMA COUNTER (K771613)Actus, Inc.1978-04-10
COUNTER, RADIOASSAY, AUTO., MICROMEDIC (K780383)Micromedic Systems1978-03-22
LIQUID SCINTILLATION COUNTER (K780179)Roche Medical Electronics, Inc.1978-02-23
PRINTER (K772099)Miles Laboratories, Inc.1978-01-26
LIQ. SCINTILLATION SPECTROPHOTOMETEO (K771369)Beckman Instruments, Inc.1977-09-14
AUTO-LOGIC II SYSTEM (K771129)Abbott Laboratories1977-08-04
GAMMA GOUNTING SYS., AUTO, MODEL 1400 (K771180)G.D. Searle and Co.1977-08-03
RADIOASSAY TUBES & RADIOASSAY TUBE CAPS (K770740)G.D. Searle and Co.1977-06-22
DP-5000 DATA REDUCTION SYSTEM (K770572)Beckman Instruments, Inc.1977-04-15
GAMMA 4000 SCINTILLATION COUNTER (K770088)Beckman Instruments, Inc.1977-02-14
WELL COUNTERS, LOGIC II (200 SERIES) (K761214)Abbott Laboratories1976-12-16
GAMMA SCINTILLATION COUNTER (K760900)Beckman Instruments, Inc.1976-11-16
LIQUID SCINTILLATION COUNTER (K760424)Beckman Instruments, Inc.1976-11-02
BLASTOMYCES YEAST ANTIGEN (K760828)I M, Inc.1976-11-01
COUNTER, RACK GAMMA (#1270) (K760470)Lkb Instruments, Inc.1976-11-01

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