FDA 510(k) Application Details - K840214

Device Classification Name Di (O-Hydroxyphenylimine) Ethane, Calcium

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510(K) Number K840214
Device Name Di (O-Hydroxyphenylimine) Ethane, Calcium
Applicant SCLAVO, INC.

, US
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Regulation Number 862.1145

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Classification Product Code CHZ
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Date Received 01/19/1984
Decision Date 03/19/1984
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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