GTX · Class I · 21 CFR 866.3740

FDA Product Code GTX: Antisera, Fluorescent, All Groups, Streptococcus Spp.

Leading manufacturers include Clinical Sciences, Inc. and Springwood Microbiologicals.

2
Total
2
Cleared
27d
Avg days
1980
Since

FDA 510(k) Cleared Antisera, Fluorescent, All Groups, Streptococcus Spp. Devices (Product Code GTX)

2 devices
1–2 of 2
Cleared Jul 28, 1981
FLUORESCENT ANTIBODY CONJUGATE FOR GP.A
K812013
Springwood Microbiologicals
Microbiology · 11d
Cleared Sep 16, 1980
STREP B POLYVALENT FLUORO-KIT
K801876
Clinical Sciences, Inc.
Microbiology · 42d

About Product Code GTX - Regulatory Context