FDA 510(k) Application Details - K821674

Device Classification Name Acid Phosphatase, Naphthyl Phosphate

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510(K) Number K821674
Device Name Acid Phosphatase, Naphthyl Phosphate
Applicant SMITH KLINE DIAGNOSTICS, INC.

, US
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Regulation Number 862.1020

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Classification Product Code CKB
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Date Received 06/07/1982
Decision Date 06/22/1982
Decision SE - Substantially Equivalent
Classification Advisory Committee HE - Hematology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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