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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K121237
Device Name BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
Applicant
CLINIQA CORPORATION
288 DISTRIBUTION STREET
SAN MARCOS,  CA  92078
Applicant Contact DAWN GAST
Correspondent
CLINIQA CORPORATION
288 DISTRIBUTION STREET
SAN MARCOS,  CA  92078
Correspondent Contact DAWN GAST
Regulation Number862.1660
Classification Product Code
JJX  
Date Received04/24/2012
Decision Date 05/18/2012
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
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