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

Antisera, Fluorescent, Herpesvirus Hominis 1,2

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

GQL is the FDA product code for Antisera, Fluorescent, Herpesvirus Hominis 1,2, a class II device type, regulated under 21 CFR 866.3305. As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GQL
Device name
Antisera, Fluorescent, 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
37
Ingested recalls
0

Clearances, product code GQL

By decision year
37 clearances under product code GQL with a decision year between 1977 and 2009, 1985 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code GQL by decision year
YearClearances
19772
19801
19813
19823
19835
19842
19858
19871
19893
19903
19912
19992
20092

Applicants with the most clearances

Product code GQL
Applicants holding the most 510(k) clearances under product code GQL
ApplicantClearances
Zeus Scientific LLC5
Immulok, Inc.4
Ortho Diagnostic Systems, Inc.3
Baxter Healthcare Corporation2
Gull Laboratories, Inc.2
Syva Co.2
Bartels & Stout, Inc.1
California Integrated Diagnostics, Inc.1
Clinical Sciences, Inc.1
Diagnon Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code