GRJ — Antigen, Cf, (Including Cf Control), Rubeola Class I

FDA Device Classification

FDA product code GRJ covers "Antigen, Cf, (Including Cf Control), Rubeola", a Class I medical device regulated under 21 CFR 866.3520. 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
GRJ
Device Class
Class I
Regulation Number
866.3520
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K843662institute virionMEASLES VIRUS RUBEOLASeptember 26, 1985
K802932orion diagnosticaMEASLES VIRUS & CONTROLSDecember 31, 1980