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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Types, Streptococcus Pneumoniae
510(k) Number K870029
Device Name IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
Applicant
American Micro Scan
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact LORRAINE WEAVER
Correspondent
American Micro Scan
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact LORRAINE WEAVER
Regulation Number866.3740
Classification Product Code
GWC  
Date Received01/05/1987
Decision Date 03/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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