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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K102700
Device Name LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
Applicant
Alere, San Diego, Dba Biosite INcorporated, Dba IN
9975 Summers Ridge Rd.
San Deigo,  CA  92121
Applicant Contact EDWARD BREHM
Correspondent
Alere, San Diego, Dba Biosite INcorporated, Dba IN
9975 Summers Ridge Rd.
San Deigo,  CA  92121
Correspondent Contact EDWARD BREHM
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/20/2010
Decision Date 12/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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