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510(k) K875173

KODAK EKTACHEM DT SLIDES (LIPA) by Eastman Kodak Company — Product Code CHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1988
Date Received
December 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase-Esterase, Enzymatic, Photometric, Lipase
Device Class
Class I
Regulation Number
862.1465
Review Panel
CH
Submission Type

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  • K941085 — LIPASE-PS ASSAY PROCEDURE NO. 805 (May 17, 1994)
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  • K900827 — COLORIMETRIC CHLORIDE PRODUCT #4314125 (May 2, 1990)