SENTINEL LIPASE LIQUID MODEL 17.401B— 510(k) K961179

Name: FDA 510(k) clearance K961179
Creator: U.S. Food and Drug Administration
Published: 1996-07-19

Substantially Equivalent

Equal Diagnostics, Inc.

FDA 510(k) clearance K961179 for SENTINEL LIPASE LIQUID MODEL 17.401B, Substantially Equivalent on 1996-07-19. Applicant: Equal Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Equal Diagnostics, Inc.
Product code: Code CHI
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1996-03-26
Decision date: 1996-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exton, PA, US

Download summary PDF View on FDA.gov ↗

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