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510(k) K894122

Device
LEECO VIS-DISK STREP-A (EIA)
Applicant
LEECO DIAGNOSTICS, INC.
510(k) number
K894122
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-15
Date received
1989-06-12
Regulation
866.3740
Classification name
Antisera, All Groups, Streptococcus Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DANTE CAPALDI
Address
21705 Evergreen P.O. Box 5126 Southfield MI US 48075 48075

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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