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510(k) K792679

Device
HISTOPLASMA CAPSULATUM, ANTISERUM
Applicant
MERIDIAN DIAGNOSTICS, INC.
510(k) number
K792679
Product code
GMK  
Decision
Substantially Equivalent (SESE)
Decision date
1980-01-17
Date received
1979-12-27
Regulation
866.3320
Classification name
Antiserum, Positive Control, Histoplasma Capsulatum
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GMK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K792692IMMUNODIFFUSION BAND INTENSIFYING FLUIDMeridian Diagnostics, Inc.1980-01-24
K792694NEGATIVE CONTROL SERUMMeridian Diagnostics, Inc.1980-01-24
K792718HISTOPLASMA CAPSULATUM, ANTISERUMMeridian Diagnostics, Inc.1980-01-17
K791390ANTI-BLASTOMYCES SERUM #CF10027XImmuno-Mycologics, Inc.1979-08-16
K791392ANTI-HISTOPLASMA SERUM #CF10026XImmuno-Mycologics, Inc.1979-08-16
K791395ANTI-HISTOPLASMA SERUM #CF10025XImmuno-Mycologics, Inc.1979-08-16
K760831ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL)I M, Inc.1976-11-01
K760832ANTI-HISTOPLASMA CONTROL SERUM (YEAST)I M, Inc.1976-11-01

Legacy Summary#

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FDA Review#

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