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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
510(k) Number K023947
Device Name GC OIA
Applicant
Thermo Biostar, Inc.
331 S. 104th St.
Louisville,  CO  80027
Applicant Contact JOHN G ADAMS
Correspondent
Thermo Biostar, Inc.
331 S. 104th St.
Louisville,  CO  80027
Correspondent Contact JOHN G ADAMS
Regulation Number866.3390
Classification Product Code
LIR  
Date Received11/27/2002
Decision Date 04/17/2003
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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