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

Anti-Human Globulin, Fta-Abs Test

21 CFR 866.3830 / Microbiology
FDA source (opens on fda.gov)

GMS is the FDA product code for Anti-Human Globulin, Fta-Abs Test, a class II device type, regulated under 21 CFR 866.3830. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GMS
Device name
Anti-Human Globulin, Fta-Abs Test
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code GMS

By decision year
3 clearances under product code GMS with a decision year between 1978 and 1985, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GMS by decision year
YearClearances
19781
19841
19851

Applicants with the most clearances

Product code GMS
Applicants holding the most 510(k) clearances under product code GMS
ApplicantClearances
Immuno-Products Industries2
Zeus Scientific LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code