LHK · Class II · 21 CFR 866.3165

FDA Product Code LHK: Antigen, Id, Candida Albicans

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, American Scientific Products and Nolan Biological Laboratories, Inc..

4
Total
4
Cleared
68d
Avg days
1981
Since

FDA 510(k) Cleared Antigen, Id, Candida Albicans Devices (Product Code LHK)

4 devices
1–4 of 4
Cleared Oct 16, 1989
DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST
K893753
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 150d
Cleared Dec 28, 1982
CANDIDA DETECTION SYSTEM
K823016
Ramco Laboratories, Inc.
Microbiology · 77d
Cleared Oct 23, 1981
REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
K812741
Nolan Biological Laboratories, Inc.
Microbiology · 24d
Cleared Aug 25, 1981
CANDIDA IMMUNODIFFUSION SYSTEM
K812186
American Scientific Products
Microbiology · 22d

About Product Code LHK - Regulatory Context