FDA 510(k) Application Details - K874302

Device Classification Name Enzyme Controls (Assayed And Unassayed)

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510(K) Number K874302
Device Name Enzyme Controls (Assayed And Unassayed)
Applicant QUANTIMETRIX MEDICAL INDUSTRIES
11953 SOUTH PRAIRIE AVE.
HAWTHORNE, CA US
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Contact ERNEST S JOHNSON
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Regulation Number 862.1660

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Classification Product Code JJT
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Date Received 10/20/1987
Decision Date 02/02/1988
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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