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

Antigens, Febrile (Weil-Felix), All Groups

21 CFR 866.3410 / Microbiology
FDA source (opens on fda.gov)

GSZ is the FDA product code for Antigens, Febrile (Weil-Felix), All Groups, a class I device type, regulated under 21 CFR 866.3410. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GSZ
Device name
Antigens, Febrile (Weil-Felix), All Groups
Regulation
21 CFR 866.3410
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
3
Ingested recalls
0

Clearances, product code GSZ

By decision year
3 clearances under product code GSZ with a decision year between 1976 and 1989, 1976 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GSZ by decision year
YearClearances
19762
19891

Applicants with the most clearances

Product code GSZ
Applicants holding the most 510(k) clearances under product code GSZ
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1
Gamma Biologicals, Inc.1
Investigacion Farmaceutica S.A. de C.V.1

Companies listing this code with FDA

Companies whose registered establishments list this code