FDA 510(k) Application Details - K800550

Device Classification Name Oil Emulsion/Thymolphthalein (Titrimetric), Lipase

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510(K) Number K800550
Device Name Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
Applicant THE DOW CHEMICAL CO.

, US
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Regulation Number 862.1465

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Classification Product Code CFG
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Date Received 03/10/1980
Decision Date 04/02/1980
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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