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

Antigens, Cf, All, Mycoplasma Spp.

21 CFR 866.3375 / Microbiology
FDA source (opens on fda.gov)

GSB is the FDA product code for Antigens, Cf, All, Mycoplasma Spp., a class I device type, regulated under 21 CFR 866.3375. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GSB
Device name
Antigens, Cf, All, Mycoplasma Spp.
Regulation
21 CFR 866.3375
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
5
Ingested recalls
0

Clearances, product code GSB

By decision year
5 clearances under product code GSB with a decision year between 1980 and 1985, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GSB by decision year
YearClearances
19801
19831
19842
19851

Applicants with the most clearances

Product code GSB
Applicants holding the most 510(k) clearances under product code GSB
ApplicantClearances
Hillcrest Biologicals1
Institute Virion, Ltd.1
Microbix Biosystems, Inc.1
Miles Laboratories, Inc.1
Orion Diagnostica, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code