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

Antiserum, Cf, Cytomegalovirus

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

GQI is the FDA product code for Antiserum, Cf, Cytomegalovirus, a class II device type, regulated under 21 CFR 866.3175. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GQI
Device name
Antiserum, Cf, 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
18
Ingested recalls
0

Clearances, product code GQI

By decision year
18 clearances under product code GQI with a decision year between 1985 and 1995, 1985 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GQI by decision year
YearClearances
19855
19865
19873
19881
19891
19941
19952

Applicants with the most clearances

Product code GQI
Applicants holding the most 510(k) clearances under product code GQI
ApplicantClearances
Amico Lab, Inc.2
Gull Laboratories, Inc.2
Labsystems, Inc.2
Pyramid Biological Corp.2
Behring Diagnostics, Inc.1
Clinical Sciences, Inc.1
Cordis US Corp.1
Cytotech, Inc.1
Diamedix Corp.1
Electro-Nucleonics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code