GOG — Antisera, Cf, Poliovirus 1-3 Class I

FDA Device Classification

FDA product code GOG covers "Antisera, Cf, Poliovirus 1-3", a Class I medical device regulated under 21 CFR 866.3405. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GOG
Device Class
Class I
Regulation Number
866.3405
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K071101meridian bioscienceTRU RSVOctober 18, 2007
K021172thermo biostarRSV OIASeptember 13, 2002
K853278hillcrest biologicalsPOLIO TYPE I CF ANTIGEN, & TYPE II, IIINovember 7, 1985