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510(k) K792681

Device
BLASTOMYCES DERMATITIDIS POS/CONTROL
Applicant
MERIDIAN DIAGNOSTICS, INC.
510(k) number
K792681
Product code
KFH  
Decision
Substantially Equivalent (SESE)
Decision date
1980-01-17
Date received
1979-12-27
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#

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 KFH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880029EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001Immuno-Mycologics, Inc.1988-02-24
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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