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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name urinalysis controls (assayed and unassayed)
510(k) Number K874890
Device Name QUANTIMETRIX URINE DIPSTICK CONTROL
Original Applicant
QUANTIMETRIX MEDICAL INDUSTRIES
11953 south prairie ave.
hawthorne,  CA  90250
Original Contact ernest s johnson
Regulation Number862.1660
Classification Product Code
JJW  
Date Received12/01/1987
Decision Date 01/21/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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