ABBOTT A-GENT LIPASE REAGENT— 510(k) K884596

Name: FDA 510(k) clearance K884596
Creator: U.S. Food and Drug Administration
Published: 1988-12-06

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K884596 for ABBOTT A-GENT LIPASE REAGENT, Substantially Equivalent on 1988-12-06. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CHI
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1988-11-03
Decision date: 1988-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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