Product code LRF

Device name: Candida Spp., Direct Antigen, Id
Medical specialty: Microbiology
Device class: 2
Regulation number: 866.3165
Review panel: MI
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K883118	ON THE SPOT CANDIDASURE	Medi-Tech, Inc.	1988-09-30
K863499	CANDIDATE(R) SUPER	Mercia Diagnostics , Ltd.	1987-03-19
K843286	EI-CANDIDA ENZYME IMMUNOASSAY EI1001	Immuno-Mycologics, Inc.	1984-10-01