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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, Toxoplasma Gondii
510(k) Number K963289
Device Name INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY
Applicant
Incstar Corp.
1990 Industrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact MARY FRICK
Correspondent
Incstar Corp.
1990 Industrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact MARY FRICK
Regulation Number866.3780
Classification Product Code
LGD  
Date Received08/21/1996
Decision Date 05/01/1997
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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