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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 K941130
Device Name ASSURE URINE HCG CONTROL
Applicant
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250 -6703
Applicant Contact EVY JOHNSON
Correspondent
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250 -6703
Correspondent Contact EVY JOHNSON
Regulation Number862.1660
Classification Product Code
JJX  
Date Received03/09/1994
Decision Date 06/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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