TRIGLYCERIDES REAGENT— 510(k) K954187

Name: FDA 510(k) clearance K954187
Creator: U.S. Food and Drug Administration
Published: 1995-10-23

Substantially Equivalent

Schiapparelli Biosystems, Inc.

FDA 510(k) clearance K954187 for TRIGLYCERIDES REAGENT, Substantially Equivalent on 1995-10-23. Applicant: Schiapparelli Biosystems, Inc.. Device class: 1.

Clearance details

Applicant: Schiapparelli Biosystems, Inc.
Product code: Code JGY
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1995-09-06
Decision date: 1995-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

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