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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
510(k) Number K955361
Device Name INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
Applicant
Incstar Corp.
1990 Industrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact MARK FRICK
Correspondent
Incstar Corp.
1990 Industrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact MARK FRICK
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received11/22/1995
Decision Date 07/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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