GTH · Class II · 21 CFR 866.3390

FDA Product Code GTH: Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae

Leading manufacturers include Syva Co. and Baxter Healthcare Corp.

3
Total
3
Cleared
55d
Avg days
1980
Since

FDA 510(k) Cleared Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae Devices (Product Code GTH)

3 devices
1–3 of 3
Cleared Jun 15, 1990
BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
K900546
Baxter Healthcare Corp
Microbiology · 130d
Cleared May 29, 1986
MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST
K861835
Syva Co.
Microbiology · 16d

About Product Code GTH - Regulatory Context