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510(k) K897150

LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT by Toyo Jozo Co., Ltd. — Product Code CHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1990
Date Received
December 26, 1989
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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