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

Antigen, Cf, Typhus Fever Group

21 CFR 866.3500 / Microbiology
FDA source (opens on fda.gov)

GPO is the FDA product code for Antigen, Cf, Typhus Fever Group, a class I device type, regulated under 21 CFR 866.3500. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GPO
Device name
Antigen, Cf, Typhus Fever Group
Regulation
21 CFR 866.3500
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
1
Ingested recalls
0

Clearances, product code GPO

By decision year
1 clearance under product code GPO with a decision year between 1992 and 1992, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GPO by decision year
YearClearances
19921

Applicants with the most clearances

Product code GPO
Applicants holding the most 510(k) clearances under product code GPO
ApplicantClearances
Behring Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code