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510(k) K883118

Device
ON THE SPOT CANDIDASURE
Applicant
MEDI-TECH, INC.
510(k) number
K883118
Product code
LRF  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-30
Date received
1988-07-25
Regulation
866.3165
Classification name
Candida Spp., Direct Antigen, Id
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JULIE DEMARCO
Address
71 Veronica Ave. P.O. Box 218 Somerset NJ US 08873 08873

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LRF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863499CANDIDATE(R) SUPERMercia Diagnostics , Ltd.1987-03-19
K843286EI-CANDIDA ENZYME IMMUNOASSAY EI1001Immuno-Mycologics, Inc.1984-10-01

Legacy Summary#

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FDA Review#

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