ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY— 510(k) K923917

Name: FDA 510(k) clearance K923917
Creator: U.S. Food and Drug Administration
Published: 1994-02-25

Substantially Equivalent

Nuclear Diagnostics, Inc.

FDA 510(k) clearance K923917 for ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY, Substantially Equivalent on 1994-02-25. 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: 1992-08-05
Decision date: 1994-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

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