GTP · Class I · 21 CFR 866.3720

FDA Product Code GTP: Exoenzymes, Multiple, Streptococcal

Leading manufacturers include American Scientific Products, Cooper Biomedical, Inc. and Bio Spec, Inc..

3
Total
3
Cleared
58d
Avg days
1982
Since

FDA 510(k) Cleared Exoenzymes, Multiple, Streptococcal Devices (Product Code GTP)

3 devices
1–3 of 3
Cleared Jan 24, 1986
STREP D FLUOR
K860041
Bio Spec, Inc.
Microbiology · 18d
Cleared Dec 27, 1983
LEAP STREP TEST KIT
K833738
Cooper Biomedical, Inc.
Immunology · 63d
Cleared Dec 19, 1982
STREPTACOCCUS CO-AGGLUTINATION KIT
K822799
American Scientific Products
Microbiology · 94d

About Product Code GTP - Regulatory Context