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

Antiserum, Francisella Tularensis

21 CFR 866.3280 / Microbiology
FDA source (opens on fda.gov)

GSK is the FDA product code for Antiserum, Francisella Tularensis, a class II device type, regulated under 21 CFR 866.3280. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
GSK
Device name
Antiserum, Francisella Tularensis
Regulation
21 CFR 866.3280
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
1
Ingested recalls
1

Clearances, product code GSK

By decision year
1 clearance under product code GSK with a decision year between 1995 and 1995, 1995 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GSK by decision year
YearClearances
19951

Applicants with the most clearances

Product code GSK
Applicants holding the most 510(k) clearances under product code GSK
ApplicantClearances
SA Scientific, Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code