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

Antigen, Cf, (Including Cf Control), Rubeola

21 CFR 866.3520 / Microbiology
FDA source (opens on fda.gov)

GRJ is the FDA product code for Antigen, Cf, (Including Cf Control), Rubeola, a class I device type, regulated under 21 CFR 866.3520. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GRJ
Device name
Antigen, Cf, (Including Cf Control), Rubeola
Regulation
21 CFR 866.3520
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code GRJ

By decision year
2 clearances under product code GRJ with a decision year between 1980 and 1985, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GRJ by decision year
YearClearances
19801
19851

Applicants with the most clearances

Product code GRJ
Applicants holding the most 510(k) clearances under product code GRJ
ApplicantClearances
Institute Virion, Ltd.1
Orion Diagnostica, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GRJ.