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

Antisera, Fluorescent, All Types, Hemophilus Spp.

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

GRO is the FDA product code for Antisera, Fluorescent, All Types, Hemophilus Spp., a class II device type, regulated under 21 CFR 866.3300. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GRO
Device name
Antisera, Fluorescent, All Types, Hemophilus Spp.
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
4
Ingested recalls
1

Clearances, product code GRO

By decision year
4 clearances under product code GRO with a decision year between 1980 and 1985, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GRO by decision year
YearClearances
19802
19841
19851

Applicants with the most clearances

Product code GRO
Applicants holding the most 510(k) clearances under product code GRO
ApplicantClearances
Armkel, LLC1
Hologic, Inc.1
Pharmacia, Inc.1
Remel Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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