510(k) K792713

Device: CANDIDA ALBICANS, ANTISERUM
Applicant: MERIDIAN DIAGNOSTICS, INC.
510(k) number: K792713
Product code: GMI
Decision: Substantially Equivalent (SESE)
Decision date: 1980-01-23
Date received: 1979-12-27
Regulation: 866.3135
Classification name: Antigen, Cf And / Or Id, Coccidioides Immitis
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#

1524213
1627497

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GMI #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K894617	OLYMPUS PK-TP SYSTEM REACTIVE CONTROL	Schiff & Co.	1989-10-31
K812190	COCCIDIOIDES IMMUNODIFFUSION SYSTEM	American Scientific Products	1981-08-31
K812185	FUNGAL IMMUNODIFFUSION SYSTEM	American Scientific Products	1981-08-25
K802129	IMMUNODIFFUSION REAGENTS/SEROLOGICAL	Nolan Biological Laboratories, Inc.	1980-09-26
K792716	CANDIDA ALBICANS, ANTIGEN	Meridian Diagnostics, Inc.	1980-01-24
K792682	COCCIDIOIDES IMMITIS, ANTIGEN	Meridian Diagnostics, Inc.	1980-01-17
K792689	COCCIDIOIDES IMMITIS, ANTIGEN	Meridian Diagnostics, Inc.	1980-01-17
K791383	CANDIDA IMMUNODIFFUSION KIT #CA1001	Immuno-Mycologics, Inc.	1979-08-16
K791389	COCCIDIOIDES ANTIGEN #CF10023X	Immuno-Mycologics, Inc.	1979-08-16
K770527	CANDIDA IMMUNODIFFUSION KIT	I M, Inc.	1978-03-17

Legacy Summary#

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