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

Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.

21 CFR 866.3550 / Microbiology
FDA source (opens on fda.gov)

GNC is the FDA product code for Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp., a class II device type, regulated under 21 CFR 866.3550. As of , FDA records hold 60 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
GNC
Device name
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
Regulation
21 CFR 866.3550
Device class
Class II
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
60
Ingested recalls
5

Clearances, product code GNC

By decision year
60 clearances under product code GNC with a decision year between 1979 and 1997, 1996 the highest year at 42.
Show the numbers
510(k) clearances under FDA product code GNC by decision year
YearClearances
19791
19801
19881
19957
199642
19978

Applicants with the most clearances

Product code GNC
Applicants holding the most 510(k) clearances under product code GNC
ApplicantClearances
SA Scientific, Ltd49
Lee Laboratories, Inc.8
BD Becton Dickinson Vacutainer Systems Preanalytic1
Immunostics, Inc.1
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code