510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JJJClass I

Counter (Beta, Gamma) For Clinical Use

21 CFR 862.2320 / Clinical Chemistry
FDA source (opens on fda.gov)

JJJ is the FDA product code for Counter (Beta, Gamma) For Clinical Use, a class I device type, regulated under 21 CFR 862.2320. As of , FDA records hold 63 510(k) clearances under this code, the most recent dated , and 14 recalls.

Classification record

Product code
JJJ
Device name
Counter (Beta, Gamma) For Clinical Use
Regulation
21 CFR 862.2320
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
63
Ingested recalls
14

Clearances, product code JJJ

By decision year
63 clearances under product code JJJ with a decision year between 1976 and 1996, 1978 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code JJJ by decision year
YearClearances
19765
19776
19789
19792
19806
19812
19826
19838
19843
19853
19861
19874
19893
19902
19921
19951
19961

Applicants with the most clearances

Product code JJJ
Applicants holding the most 510(k) clearances under product code JJJ
ApplicantClearances
Beckman Instruments, Inc.7
Kemble Instruments, Inc.6
Lkb Instruments, Inc.5
Abbott Medical4
Micromedic Systems4
Actus, Inc.3
Iso-Data, Inc.3
Medical & Scientific Designs, Inc.3
Nuclear Ent., Ltd.3
Mirion Technologies (Capintec), Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code