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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
Models 83042, 83043, 83045, 83046
Device Name BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
Original Applicant
CLINIQA CORPORATION
288 distribution street
san marcos,  CA  92078
Original Contact dawn gast
Regulation Number862.1660
Classification Product Code
JJX  
Date Received04/24/2012
Decision Date 05/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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