GQQ — Antisera, Hai, Parainfluenza Virus 1-4 Class I

FDA Device Classification

FDA product code GQQ covers "Antisera, Hai, Parainfluenza Virus 1-4", a Class I medical device regulated under 21 CFR 866.3400. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
GQQ
Device Class
Class I
Regulation Number
866.3400
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K780007northeast biomedical labsGOAT ANTI-INFLUENZA ANTISERAJanuary 20, 1978