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

Antigen, Latex Agglutination, Trichinella Spiralis

21 CFR 866.3850 / Microbiology
FDA source (opens on fda.gov)

GPG is the FDA product code for Antigen, Latex Agglutination, Trichinella Spiralis, a class I device type, regulated under 21 CFR 866.3850. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GPG
Device name
Antigen, Latex Agglutination, Trichinella Spiralis
Regulation
21 CFR 866.3850
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
2
Ingested recalls
0

Clearances, product code GPG

By decision year
2 clearances under product code GPG with a decision year between 1988 and 1991, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GPG by decision year
YearClearances
19881
19911

Applicants with the most clearances

Product code GPG
Applicants holding the most 510(k) clearances under product code GPG
ApplicantClearances
Lmd Laboratories1
Utah Bioresearch, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GPG.