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

Antisera, Neutralization, Influenza Virus A, B, C

21 CFR 866.3330 / Microbiology
FDA source (opens on fda.gov)

GNR is the FDA product code for Antisera, Neutralization, Influenza Virus A, B, C, a class I device type, regulated under 21 CFR 866.3330. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GNR
Device name
Antisera, Neutralization, Influenza Virus A, B, C
Regulation
21 CFR 866.3330
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
1
Ingested recalls
0

Clearances, product code GNR

By decision year
1 clearance under product code GNR with a decision year between 1999 and 1999, 1999 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GNR by decision year
YearClearances
19991

Applicants with the most clearances

Product code GNR
Applicants holding the most 510(k) clearances under product code GNR
ApplicantClearances
Zymetx, 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 GNR.