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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 K880701
Device Name QUANTIMETRIX SERUM ENZYME CONTROL
Applicant
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250
Applicant Contact JOHNSON, III
Correspondent
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250
Correspondent Contact JOHNSON, III
Regulation Number862.1660
Classification Product Code
JJT  
Date Received02/22/1988
Decision Date 03/24/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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