DAA · Class II · 21 CFR 866.5510

FDA Product Code DAA: Igg, Peroxidase, Antigen, Antiserum, Control

Leading manufacturers include Clinical Sciences, Inc., Diagnostic Reagent Tech. and Breit Laboratories, Inc..

5
Total
5
Cleared
55d
Avg days
1979
Since

FDA 510(k) Cleared Igg, Peroxidase, Antigen, Antiserum, Control Devices (Product Code DAA)

5 devices
1–5 of 5
Cleared Sep 12, 1983
ANA MICROZYME TEST SYS #1610
K832675
Clinical Sciences, Inc.
Immunology · 34d
Cleared Jul 18, 1983
ANTINUCLEAR ANTIBODY TEST KIT
K831927
Breit Laboratories, Inc.
Immunology · 33d
Cleared Jun 02, 1983
IP SPECIFIC G
K830005
Diagnostic Reagent Tech.
Chemistry · 150d
Cleared Oct 22, 1982
ANAZYME ANA PEROXIDASE TEST SYSTEM
K822911
Clinical Sciences, Inc.
Immunology · 21d
Cleared Oct 17, 1979
INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL
K791749
Clinical Sciences, Inc.
Immunology · 37d

About Product Code DAA - Regulatory Context