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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Serological, Positive Control
510(k) Number K974262
Device Name SYSCOS IDC - G, IDC, BSC, IDC - G
Applicant
Scantibodies Laboratory, Inc.
9336 Abraham Way
Santee,  CA  92071
Applicant Contact RICHARD LENART
Correspondent
Scantibodies Laboratory, Inc.
9336 Abraham Way
Santee,  CA  92071
Correspondent Contact RICHARD LENART
Regulation Number862.1660
Classification Product Code
MJX  
Subsequent Product Code
MJY  
Date Received11/13/1997
Decision Date 12/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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