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

Antisera, All Types, Shigella Spp.

21 CFR 866.3660 / Microbiology
FDA source (opens on fda.gov)

GNB is the FDA product code for Antisera, All Types, Shigella Spp., a class II device type, regulated under 21 CFR 866.3660. As of , FDA records hold 41 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
GNB
Device name
Antisera, All Types, Shigella Spp.
Regulation
21 CFR 866.3660
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
41
Ingested recalls
3

Clearances, product code GNB

By decision year
41 clearances under product code GNB with a decision year between 1982 and 1996, 1996 the highest year at 24.
Show the numbers
510(k) clearances under FDA product code GNB by decision year
YearClearances
19821
19891
19901
199514
199624

Applicants with the most clearances

Product code GNB
Applicants holding the most 510(k) clearances under product code GNB
ApplicantClearances
SA Scientific, Ltd38
Analytical Products, Inc.1
Pharmacia, Inc.1
Wellcome Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code