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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name glucose oxidase, glucose
510(k) Number K120615
Device Name ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
Applicant
ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN
9975 SUMMERS RIDGE RD
SAN DIEGO,  CA  92121
Applicant Contact EDWARD BREHM, PH.D.
Correspondent
ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN
9975 SUMMERS RIDGE RD
SAN DIEGO,  CA  92121
Correspondent Contact EDWARD BREHM, PH.D.
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
CHH   JGY   JJE   LBS  
Date Received02/29/2012
Decision Date 05/15/2013
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
Recalls CDRH Recalls
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