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510(k) K770364

ACA LIPASE ANALYTICAL TEST PACK by E.I. Dupont DE Nemours & Co., Inc. — Product Code CET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1977
Date Received
February 23, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Olive Oil Emulsion (Turbidimetric), Lipase
Device Class
Class I
Regulation Number
862.1465
Review Panel
CH
Submission Type

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  • K862440 — PARAMAX LIPASE REAGENT (August 4, 1986)
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