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

Antiserum, Fluorescent, Q Fever

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

GPJ is the FDA product code for Antiserum, Fluorescent, Q Fever, a class I device type, regulated under 21 CFR 866.3500. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GPJ
Device name
Antiserum, Fluorescent, Q Fever
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
2
Ingested recalls
0

Clearances, product code GPJ

By decision year
2 clearances under product code GPJ with a decision year between 1992 and 1992, 1992 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GPJ by decision year
YearClearances
19922

Applicants with the most clearances

Product code GPJ
Applicants holding the most 510(k) clearances under product code GPJ
ApplicantClearances
Hillcrest Biologicals2

Companies listing this code with FDA

Companies whose registered establishments list this code