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

Antisera, Fluorescent, Brucella Spp.

21 CFR 866.3085 / Microbiology
FDA source (opens on fda.gov)

GSM is the FDA product code for Antisera, Fluorescent, Brucella Spp., a class II device type, regulated under 21 CFR 866.3085. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
GSM
Device name
Antisera, Fluorescent, Brucella Spp.
Regulation
21 CFR 866.3085
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
4
Ingested recalls
4

Clearances, product code GSM

By decision year
4 clearances under product code GSM with a decision year between 1995 and 1995, 1995 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GSM by decision year
YearClearances
19954

Applicants with the most clearances

Product code GSM
Applicants holding the most 510(k) clearances under product code GSM
ApplicantClearances
SA Scientific, Ltd4

Companies listing this code with FDA

Companies whose registered establishments list this code