GSB · Class I · 21 CFR 866.3375

FDA Product Code GSB: Antigens, Cf, All, Mycoplasma Spp.

Leading manufacturers include Orion Diagnostica, Inc., Miles Laboratories, Inc. and Hillcrest Biologicals.

5
Total
5
Cleared
52d
Avg days
1980
Since

FDA 510(k) Cleared Antigens, Cf, All, Mycoplasma Spp. Devices (Product Code GSB)

5 devices
1–5 of 5
Cleared Aug 01, 1985
MYCOPLASMA SPP SEROLOGICAL REAGENTS
K852933
Microbix Biosystems, Inc.
Microbiology · 23d
Cleared Oct 25, 1984
MYCOPLASMA PNEUMONIAE
K843664
Institute Virion , Ltd.
Microbiology · 38d
Cleared Feb 27, 1984
MYCOPLASMA PNEUMONIAE CF ANTIGEN
K834338
Hillcrest Biologicals
Microbiology · 77d
Cleared Sep 20, 1983
SERA-TEK MYCOPLASMA ANTIBODY TEST
K832132
Miles Laboratories, Inc.
Immunology · 81d
Cleared Dec 31, 1980
MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL
K802934
Orion Diagnostica, Inc.
Microbiology · 42d

About Product Code GSB - Regulatory Context