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

Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4

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

GQR is the FDA product code for Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4, a class I device type, regulated under 21 CFR 866.3400. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GQR
Device name
Antigens, Ha (Including Ha Control), 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
1
Ingested recalls
0

Clearances, product code GQR

By decision year
1 clearance under product code GQR with a decision year between 1981 and 1981, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GQR by decision year
YearClearances
19811

Applicants with the most clearances

Product code GQR
Applicants holding the most 510(k) clearances under product code GQR
ApplicantClearances
Dutchland Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code