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FDA 510(k) Application Details - K943366
Device Classification Name
Acid Phosphatase, Naphthyl Phosphate
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510(K) Number
K943366
Device Name
Acid Phosphatase, Naphthyl Phosphate
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD, MA 01730 US
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Contact
WALLIS W CADY
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Regulation Number
862.1020
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Classification Product Code
CKB
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More FDA Info for this Product Code
Date Received
07/13/1994
Decision Date
01/29/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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