LRF · Class II · 21 CFR 866.3165

FDA Product Code LRF: Candida Spp., Direct Antigen, Id

Leading manufacturers include Immuno-Mycologics, Inc., Mercia Diagnostics , Ltd. and Medi-Tech, Inc..

3
Total
3
Cleared
100d
Avg days
1984
Since

FDA 510(k) Cleared Candida Spp., Direct Antigen, Id Devices (Product Code LRF)

3 devices
1–3 of 3
Cleared Sep 30, 1988
ON THE SPOT CANDIDASURE
K883118
Medi-Tech, Inc.
Microbiology · 67d
Cleared Mar 19, 1987
CANDIDATE(R) SUPER
K863499
Mercia Diagnostics , Ltd.
Microbiology · 191d
Cleared Oct 01, 1984
EI-CANDIDA ENZYME IMMUNOASSAY EI1001
K843286
Immuno-Mycologics, Inc.
Microbiology · 41d

About Product Code LRF - Regulatory Context