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

Antiserum, Typhus Fever

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

GPN is the FDA product code for Antiserum, Typhus Fever, 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 one recall.

Classification record

Product code
GPN
Device name
Antiserum, Typhus 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
1
Ingested recalls
1

Clearances, product code GPN

By decision year
1 clearance under product code GPN with a decision year between 1987 and 1987, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GPN by decision year
YearClearances
19871

Applicants with the most clearances

Product code GPN
Applicants holding the most 510(k) clearances under product code GPN
ApplicantClearances
Hillcrest Biologicals1

Companies listing this code with FDA

Companies whose registered establishments list this code