TRIGLYCERIDES-GPO REAGENT— 510(k) K842029

Name: FDA 510(k) clearance K842029
Creator: U.S. Food and Drug Administration
Published: 1984-07-09

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K842029 for TRIGLYCERIDES-GPO REAGENT, Substantially Equivalent on 1984-07-09. Applicant: Reagents Applications, Inc.. Device class: 1.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1984-05-18
Decision date: 1984-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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