GTN · Class I · 21 CFR 866.3700

FDA Product Code GTN: Antisera, Fluorescent, All Types, Staphylococcus Spp.

Leading manufacturers include Oxoid U.S.A., Inc. and Volu Sol Medical Industries.

4
Total
4
Cleared
171d
Avg days
1979
Since

FDA 510(k) Cleared Antisera, Fluorescent, All Types, Staphylococcus Spp. Devices (Product Code GTN)

4 devices
1–4 of 4
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT SET-RPLA
K855233
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT TST-RPLA
K855236
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Sep 24, 1979
AGGLUTINOTEST-STAPHYLOLISIN
K791453
Volu Sol Medical Industries
Microbiology · 49d

About Product Code GTN - Regulatory Context