GOA — Antisera, Cf, Adenovirus 1-33 Class I

FDA Device Classification

FDA product code GOA covers "Antisera, Cf, Adenovirus 1-33", a Class I medical device regulated under 21 CFR 866.3020. 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
GOA
Device Class
Class I
Regulation Number
866.3020
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K872698sitaADENOVIRUS CF ANTIGEN AND CONTROL ANTIGENSeptember 18, 1987