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

Antisera, Cf, Influenza Virus A, B, C

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

GNW is the FDA product code for Antisera, Cf, Influenza Virus A, B, C, a class I device type, regulated under 21 CFR 866.3330. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GNW
Device name
Antisera, Cf, 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
16
Ingested recalls
2

Clearances, product code GNW

By decision year
16 clearances under product code GNW with a decision year between 1987 and 2009, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GNW by decision year
YearClearances
19872
19901
19912
19942
19961
19971
19981
20001
20021
20061
20081
20092

Applicants with the most clearances

Product code GNW
Applicants holding the most 510(k) clearances under product code GNW
ApplicantClearances
Ortho-Clinical Diagnostics, Inc.5
Dako Diagnostics, Ltd.2
Gull Laboratories, Inc.2
Neogenex2
Sita, Inc.2
Baxter Healthcare Corporation1
Intracel Corp.1
Light Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code