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

Antigens, Ha (Including Ha Control), Influenza Virus A, B, C

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

GNT is the FDA product code for Antigens, Ha (Including Ha Control), Influenza Virus A, B, C, a class I device type, regulated under 21 CFR 866.3330. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GNT
Device name
Antigens, Ha (Including Ha Control), 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
5
Ingested recalls
0

Clearances, product code GNT

By decision year
5 clearances under product code GNT with a decision year between 1978 and 1996, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GNT by decision year
YearClearances
19782
19901
19911
19961

Applicants with the most clearances

Product code GNT
Applicants holding the most 510(k) clearances under product code GNT
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic2
Flow Laboratories, Inc.2
Zymetx, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code