GSA · Class I · 21 CFR 866.3375

FDA Product Code GSA: Antisera, All Mycoplasma Spp.

Leading manufacturers include Medical Diagnostic Technologies, Inc., Intl. Mycoplasma/Mdc Assoc. and Meridian Diagnostics, Inc..

6
Total
6
Cleared
120d
Avg days
1986
Since

FDA 510(k) Cleared Antisera, All Mycoplasma Spp. Devices (Product Code GSA)

6 devices
1–6 of 6
Cleared Oct 17, 1995
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM
K950073
Shared Systems, Inc.
Microbiology · 281d
Cleared Jun 24, 1991
COLOR VUE TM- MYCOPLASMA PNEUMONIAE
K910833
Seradyn, Inc.
Microbiology · 117d
Cleared Jan 30, 1991
MERISTAR-MP
K905493
Meridian Diagnostics, Inc.
Microbiology · 54d
Cleared Dec 21, 1990
SEROFAST
K903958
Intl. Mycoplasma/Mdc Assoc.
Microbiology · 115d
Cleared Oct 25, 1988
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K883083
Medical Diagnostic Technologies, Inc.
Microbiology · 96d
Cleared Sep 03, 1986
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K862630
Medical Diagnostic Technologies, Inc.
Microbiology · 55d

About Product Code GSA - Regulatory Context