DELTATEST (R) LIPASE II— 510(k) K893718

Name: FDA 510(k) clearance K893718
Creator: U.S. Food and Drug Administration
Published: 1989-09-28

Substantially Equivalent

Electro-Nucleonics, Inc.

FDA 510(k) clearance K893718 for DELTATEST (R) LIPASE II, Substantially Equivalent on 1989-09-28. Applicant: Electro-Nucleonics, Inc.. Device class: 1.

Clearance details

Applicant: Electro-Nucleonics, Inc.
Product code: Code CET
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1989-05-17
Decision date: 1989-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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