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

Antiserum, Cf, Varicella-Zoster

21 CFR 866.3900 / Microbiology
FDA source (opens on fda.gov)

GQX is the FDA product code for Antiserum, Cf, Varicella-Zoster, a class II device type, regulated under 21 CFR 866.3900. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GQX
Device name
Antiserum, Cf, Varicella-Zoster
Regulation
21 CFR 866.3900
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
Yes
Ingested clearances
11
Ingested recalls
2

Clearances, product code GQX

By decision year
11 clearances under product code GQX with a decision year between 1977 and 1996, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GQX by decision year
YearClearances
19772
19841
19852
19861
19871
19881
19891
19911
19961

Applicants with the most clearances

Product code GQX
Applicants holding the most 510(k) clearances under product code GQX
ApplicantClearances
Flow Laboratories, Inc.2
Gull Laboratories, Inc.2
Behring Diagnostics, Inc.1
Electro-Nucleonics, Inc.1
Great Lakes Bioscience1
Idt, A Division of Whittaker M.A. Bioproducts1
Light Diagnostics1
Microbix Biosystems, Inc.1
Ortho Diagnostic Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code