GTP — Exoenzymes, Multiple, Streptococcal Class I

FDA Device Classification

FDA product code GTP covers "Exoenzymes, Multiple, Streptococcal", a Class I medical device regulated under 21 CFR 866.3720. 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
GTP
Device Class
Class I
Regulation Number
866.3720
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K860041bio specSTREP D FLUORJanuary 24, 1986
K833738cooper biomedicalLEAP STREP TEST KITDecember 27, 1983
K822799american scientific productsSTREPTACOCCUS CO-AGGLUTINATION KITDecember 19, 1982