GLZ · Class II · 21 CFR 866.3780

FDA Product Code GLZ: Antigens, If, Toxoplasma Gondii

Leading manufacturers include Gull Laboratories, Inc., Intl. Diagnostic Technology and Zeus Scientific, Inc..

18
Total
18
Cleared
79d
Avg days
1977
Since

FDA 510(k) Cleared Antigens, If, Toxoplasma Gondii Devices (Product Code GLZ)

18 devices
1–18 of 18
Cleared Mar 23, 1993
TOXOPLASMA IGM IFA TEST SYSTEM
K924882
Zeus Scientific, Inc.
Microbiology · 176d
Cleared Mar 17, 1988
TOXO IGM TEST
K880007
Gull Laboratories, Inc.
Microbiology · 73d
Cleared Apr 30, 1985
FIAX TOXO-M ANTIBODIES TEST KIT
K850591
Intl. Diagnostic Technology
Microbiology · 75d
Cleared Aug 28, 1984
ANTI-TOXOPLASMA GONDII KIT
K842664
Amico Lab, Inc.
Immunology · 49d
Cleared Sep 24, 1979
TOXOPLASMA ANTIBODY TEST SYSTEM
K791571
Zeus Scientific, Inc.
Microbiology · 42d
Cleared Jun 13, 1979
FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO
K790464
Intl. Diagnostic Technology
Microbiology · 100d
Cleared May 22, 1979
QUANTAZYME TOXOPLASMA
K790360
Bio-Rad
Microbiology · 89d
Cleared Jun 28, 1978
IMMUNOZYME TOXOPLASMA ANTIBODY
K780352
Millipore Corp.
Microbiology · 117d
Cleared Dec 22, 1977
TOXO TEST
K772243
Gull Laboratories, Inc.
Toxicology · 14d

About Product Code GLZ - Regulatory Context