GNL — Antigens, Cf (Including Cf Control), Echovirus 1-34 Class I

FDA Device Classification

FDA product code GNL covers "Antigens, Cf (Including Cf Control), Echovirus 1-34", a Class I medical device regulated under 21 CFR 866.3205. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GNL
Device Class
Class I
Regulation Number
866.3205
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K844967hillcrest biologicalsECHO TYPE 9 CF ANTIGENMarch 5, 1985
K844695hillcrest biologicalsECHO TYPE 4 CF ANTIGENMarch 5, 1985