NUCLIPASE (I125) PANCREATIC LIPASE— 510(k) K823860

Name: FDA 510(k) clearance K823860
Creator: U.S. Food and Drug Administration
Published: 1983-04-18

Substantially Equivalent

Nuclear Diagnostics, Inc.

FDA 510(k) clearance K823860 for NUCLIPASE (I125) PANCREATIC LIPASE, Substantially Equivalent on 1983-04-18. Applicant: Nuclear Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Nuclear Diagnostics, Inc.
Product code: Code CET
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1982-12-22
Decision date: 1983-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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