JJJ · Class I · 21 CFR 862.2320

FDA Product Code JJJ: Counter (beta, Gamma) For Clinical Use

Leading manufacturers include Beckman Instruments, Inc., Kemble Instruments, Inc. and Lkb Instruments, Inc..

63
Total
63
Cleared
60d
Avg days
1976
Since
63 devices
25–48 of 63
Cleared Aug 08, 1983
NML-5010/5020 MULTI-DETECTOR SYSTEM
K832002
Nuclear Medical Laboratories, Inc.
Chemistry · 47d
Cleared Apr 06, 1983
KEMTEK 102
K830751
Kemble Instruments, Inc.
Chemistry · 27d
Cleared Mar 10, 1983
KINETI COUNT 48 IMMUNOASSAY SYSTEM
K830365
Medical & Scientific Designs, Inc.
Chemistry · 34d
Cleared Dec 03, 1982
CAP-RIA 16
K823240
Capintec, Inc.
Chemistry · 32d
Cleared Aug 24, 1982
IMMU-COUNT 404
K822293
Kemble Instruments, Inc.
Chemistry · 22d
Cleared Jul 13, 1982
PHILLIPS RADIATION MEASURING INSTRUMENT
K821892
Long Island Scientific
Chemistry · 15d
Cleared Jun 03, 1982
RIA STAT 16
K821494
E. R. Squibb & Sons, Inc.
Chemistry · 16d
Cleared Mar 16, 1982
MICROMEDIC SYSTEMS ISOFLEX
K820376
Micromedic Systems
Radiology · 35d
Cleared Feb 05, 1982
IMMU-COUNT
K820137
Kemble Instruments, Inc.
Chemistry · 18d
Cleared Dec 29, 1981
LS 5800 SERIES LIQUID SCINTILLATION
K813472
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Feb 25, 1981
LIQUID SCINTILLATION SPECTROPHOTOMETER
K810345
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Dec 18, 1980
PACE-4-AUTOMATIC RIA GAMMA-COUTER
K802578
Philips Medical Systems (Cleveland), Inc.
Radiology · 59d
Cleared Jun 26, 1980
NUCLEAR ENTERPRISES 1600/GAMMA COUNTER
K801264
Nuclear Ent. , Ltd.
Toxicology · 29d
Cleared Jun 20, 1980
ATOMLIGHT (LIQUID SCINTILLATION SOLUTION
K801245
New England Nuclear
Toxicology · 24d
Cleared Jun 20, 1980
NUCLEAR ENTERPRISES 1612 MULTI-WELL
K801263
Nuclear Ent. , Ltd.
Toxicology · 23d
Cleared Apr 10, 1980
HYDRAGAMMA 16
K800601
Innotron of Oregon, Inc.
Chemistry · 24d
Cleared Mar 12, 1980
NML 5000 AUTO. GAMMA SCINT. COUNTER
K800388
Nuclear Medical Laboratories, Inc.
Toxicology · 16d
Cleared Jun 28, 1979
LIQUID SCINTILLATION COUNTER
K790961
Nuclear Ent. , Ltd.
Chemistry · 37d
Cleared Jun 15, 1979
NUCLEAR SAMPLE READER
K790905
Abbott Laboratories
Toxicology · 35d
Cleared Jun 22, 1978
IDI 200 GAMMA COUNTER
K780790
Iso-Data, Inc.
Radiology · 38d
Cleared May 26, 1978
SCINTILLATION, LIQUID, RACKBETA
K780341
Lkb Instruments, Inc.
Radiology · 86d
Cleared Apr 12, 1978
AUTO. WELL TYPE GAMMA COUNTERS
K771614
Actus, Inc.
Chemistry · 232d
Cleared Apr 12, 1978
GAMMA COUNTER
K780344
Lkb Instruments, Inc.
Chemistry · 42d
Cleared Apr 10, 1978
WELL TYPE GAMMA COUNTER
K771612
Actus, Inc.
Radiology · 230d