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

Antisera, Neutralization, Herpesvirus Hominis

21 CFR 866.3305 / Microbiology
FDA source (opens on fda.gov)

GQM is the FDA product code for Antisera, Neutralization, Herpesvirus Hominis, a class II device type, regulated under 21 CFR 866.3305. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GQM
Device name
Antisera, Neutralization, Herpesvirus Hominis
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code GQM

By decision year
3 clearances under product code GQM with a decision year between 1979 and 1988, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GQM by decision year
YearClearances
19791
19811
19881

Applicants with the most clearances

Product code GQM
Applicants holding the most 510(k) clearances under product code GQM
ApplicantClearances
Enzo Biochem, Inc.1
Microbiological Assoc.1
Vibac Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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