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

Antisera, Cf, Parainfluenza Virus 1-4

21 CFR 866.3400 / Microbiology
FDA source (opens on fda.gov)

GQT is the FDA product code for Antisera, Cf, Parainfluenza Virus 1-4, a class I device type, regulated under 21 CFR 866.3400. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GQT
Device name
Antisera, Cf, Parainfluenza Virus 1-4
Regulation
21 CFR 866.3400
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code GQT

By decision year
4 clearances under product code GQT with a decision year between 1978 and 1987, 1987 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GQT by decision year
YearClearances
19781
19873

Applicants with the most clearances

Product code GQT
Applicants holding the most 510(k) clearances under product code GQT
ApplicantClearances
Sita, Inc.3
Northeast Biomedical Labs., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code