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

Antisera, All Types, H. Influenza

21 CFR 866.3300 / Microbiology
FDA source (opens on fda.gov)

GRP is the FDA product code for Antisera, All Types, H. Influenza, a class II device type, regulated under 21 CFR 866.3300. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GRP
Device name
Antisera, All Types, H. Influenza
Regulation
21 CFR 866.3300
Device class
Class II
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
6
Ingested recalls
1

Clearances, product code GRP

By decision year
6 clearances under product code GRP with a decision year between 1982 and 1989, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GRP by decision year
YearClearances
19823
19831
19851
19891

Applicants with the most clearances

Product code GRP
Applicants holding the most 510(k) clearances under product code GRP
ApplicantClearances
American Micro Scan1
Armkel, LLC1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Diagnostica, Inc.1
Hyland Therapeutic Div., Travenol Laboratories1
Seragen Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code