FDA 510(k) Application Details - K860554

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

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510(K) Number K860554
Device Name Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
Applicant STERLING DIAGNOSTICS, INC.
34210 DEQUINDRE RD.
STERLING HEIGHTS, MI US
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Contact DAVID L CALLENDER
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Regulation Number 862.1465

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Classification Product Code CFG
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Date Received 02/14/1986
Decision Date 03/14/1986
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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