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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme controls (assayed and unassayed)
510(k) Number K030768
Device Name CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
Applicant
CLINIQA CORPORATION
1432 SOUTH MISSION RD.
FALLBROOK,  CA  92028
Applicant Contact CAROL RUGGIERO
Correspondent
CLINIQA CORPORATION
1432 SOUTH MISSION RD.
FALLBROOK,  CA  92028
Correspondent Contact CAROL RUGGIERO
Regulation Number862.1660
Classification Product Code
JJT  
Date Received03/11/2003
Decision Date 03/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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