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

Antigen, Cf (Including Cf Control), Mumps Virus

21 CFR 866.3380 / Microbiology
FDA source (opens on fda.gov)

GRC is the FDA product code for Antigen, Cf (Including Cf Control), Mumps Virus, a class I device type, regulated under 21 CFR 866.3380. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GRC
Device name
Antigen, Cf (Including Cf Control), Mumps Virus
Regulation
21 CFR 866.3380
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
3
Ingested recalls
0

Clearances, product code GRC

By decision year
3 clearances under product code GRC with a decision year between 1980 and 1991, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GRC by decision year
YearClearances
19801
19831
19911

Applicants with the most clearances

Product code GRC
Applicants holding the most 510(k) clearances under product code GRC
ApplicantClearances
Hazleton Dutchland, Inc.1
Orion Diagnostica, Inc.1
Virion (U.S.), 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 GRC.