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

Antigen, Cf (Including Cf Control), Cytomegalovirus

21 CFR 866.3175 / Microbiology
FDA source (opens on fda.gov)

GQH is the FDA product code for Antigen, Cf (Including Cf Control), Cytomegalovirus, a class II device type, regulated under 21 CFR 866.3175. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GQH
Device name
Antigen, Cf (Including Cf Control), Cytomegalovirus
Regulation
21 CFR 866.3175
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
19
Ingested recalls
1

Clearances, product code GQH

By decision year
19 clearances under product code GQH with a decision year between 1979 and 1998, 1988 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GQH by decision year
YearClearances
19792
19802
19812
19841
19851
19873
19885
19941
19971
19981

Applicants with the most clearances

Product code GQH
Applicants holding the most 510(k) clearances under product code GQH
ApplicantClearances
Litton Bionetics2
Bion Ent., Ltd.1
Clinical Sciences, Inc.1
Enzo Biochem, Inc.1
Immuno-Diagnostic Products, Inc.1
Institute Virion, Ltd.1
Intl. Diagnostic Technology1
Intracel Corp.1
Light Diagnostics1
Medical Diagnostic Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code