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

Antisera, Hai, Influenza Virus A, B, C

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

GNS is the FDA product code for Antisera, Hai, Influenza Virus A, B, C, a class I device type, regulated under 21 CFR 866.3330. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GNS
Device name
Antisera, Hai, 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
9
Ingested recalls
0

Clearances, product code GNS

By decision year
9 clearances under product code GNS with a decision year between 1978 and 1978, 1978 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code GNS by decision year
YearClearances
19789

Applicants with the most clearances

Product code GNS
Applicants holding the most 510(k) clearances under product code GNS
ApplicantClearances
Northeast Biomedical Labs., Inc.5
Flow Laboratories, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code