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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Direct Antigen, Positive Control
510(k) Number K972182
Device Name ABBOTT STREP A CONTROLS
Applicant
Abbott Diagnostics
200 Abbott Park Rd.
Dept. 9v6, Bldg. Ap31
Abbott Park,  IL  60064
Applicant Contact GRACE LEMIEUX
Correspondent
Abbott Diagnostics
200 Abbott Park Rd.
Dept. 9v6, Bldg. Ap31
Abbott Park,  IL  60064
Correspondent Contact GRACE LEMIEUX
Regulation Number862.1660
Classification Product Code
MJZ  
Date Received05/29/1997
Decision Date 08/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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