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GTP

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Exoenzymes, Multiple, Streptococcal
Device class
Class I (low risk)
Regulation
21 CFR 866.3720
Medical specialty
Microbiology
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RecordFirmDate
STREP D FLUOR (K860041)Bio Spec, Inc.1986-01-24
LEAP STREP TEST KIT (K833738)Cooper Biomedical, Inc.1983-12-27
STREPTACOCCUS CO-AGGLUTINATION KIT (K822799)American Scientific Products1982-12-19

Track GTP automatically

Every clearance here is in the API, with alerts when new ones post.