FDA 510(k) Application Details - K934922

Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)

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510(K) Number K934922
Device Name Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant UNIPATH LTD.
NORSE ROAD
BEDFORD MK41 OQG UK
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Contact LOUISE ROBERTS
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Regulation Number 862.1660

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Classification Product Code JJX
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Date Received 10/13/1993
Decision Date 12/29/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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