ENZLIPASE, ENZYMATIC LIPASE KIT— 510(k) K862312

Name: FDA 510(k) clearance K862312
Creator: U.S. Food and Drug Administration
Published: 1986-09-26

Substantially Equivalent

Nuclear Diagnostics, Inc.

FDA 510(k) clearance K862312 for ENZLIPASE, ENZYMATIC LIPASE KIT, Substantially Equivalent on 1986-09-26. Applicant: Nuclear Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Nuclear Diagnostics, Inc.
Product code: Code CHI
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1986-06-18
Decision date: 1986-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

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