GRC — Antigen, Cf (Including Cf Control), Mumps Virus Class I

FDA Device Classification

FDA product code GRC covers "Antigen, Cf (Including Cf Control), Mumps Virus", a Class I medical device regulated under 21 CFR 866.3380. 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
GRC
Device Class
Class I
Regulation Number
866.3380
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K905306virion (u.s.)MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGENJune 17, 1991
K832873hazleton dutchlandMUMPS COMPLEMENT FIXATION & HEMAGGLUDecember 27, 1983
K802933orion diagnosticaMUMPS S & V ANTIGENS & CONTROLSDecember 31, 1980