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510(k) K812186

Device
CANDIDA IMMUNODIFFUSION SYSTEM
Applicant
AMERICAN SCIENTIFIC PRODUCTS
510(k) number
K812186
Product code
LHK  
Decision
Substantially Equivalent (SESE)
Decision date
1981-08-25
Date received
1981-08-03
Regulation
866.3165
Classification name
Antigen, Id, Candida Albicans
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LHK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893753DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TESTBd Becton Dickinson Vacutainer Systems Preanalytic1989-10-16
K812741REAGENTS FOR SERODIAGNOSIS OF CANDIDOSISNolan Biological Laboratories, Inc.1981-10-23

Legacy Summary#

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FDA Review#

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