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510(k) K880029

Device
EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001
Applicant
IMMUNO-MYCOLOGICS, INC.
510(k) number
K880029
Product code
KFH  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-24
Date received
1988-01-05
Regulation
866.3060
Classification name
Antiserum, Positive Control, Blastomyces Dermatitidis
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BAUMAN, PHD
Address
P.O. Box 1151 Norman OK US 73070 73070

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KFH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K792681BLASTOMYCES DERMATITIDIS POS/CONTROLMeridian Diagnostics, Inc.1980-01-17
K792685BLASTOMYCES DERMATITIDIS, ANTISERUMMeridian Diagnostics, Inc.1980-01-17
K760833ANTI-BLASTOMYCES CONTROL SERUM (YEAST)I M, Inc.1976-11-01

Legacy Summary#

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FDA Review#

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