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

Antisera, Cf, Herpesvirus Hominis 1,2

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

GQO is the FDA product code for Antisera, Cf, Herpesvirus Hominis 1,2, a class II device type, regulated under 21 CFR 866.3305. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GQO
Device name
Antisera, Cf, Herpesvirus Hominis 1,2
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
16
Ingested recalls
1

Clearances, product code GQO

By decision year
16 clearances under product code GQO with a decision year between 1979 and 1989, 1985 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code GQO by decision year
YearClearances
19791
19856
19863
19872
19882
19892

Applicants with the most clearances

Product code GQO
Applicants holding the most 510(k) clearances under product code GQO
ApplicantClearances
Amico Lab, Inc.2
Armkel, LLC2
Clinical Sciences, Inc.2
Electro-Nucleonics, Inc.2
Behring Diagnostics, Inc.1
Bion Ent., Ltd.1
Disease Detection International, Inc.1
Electro-Nucleonics Laboratories, Inc.1
Isolab, Inc.1
Microbiological Research Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code