TRIGLYCERIDES REAGENT (PRODUCT #88218)— 510(k) K883405

Name: FDA 510(k) clearance K883405
Creator: U.S. Food and Drug Administration
Published: 1988-09-13

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K883405 for TRIGLYCERIDES REAGENT (PRODUCT #88218), Substantially Equivalent on 1988-09-13. Applicant: Hichem Diagnostics. Device class: 1.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1988-08-11
Decision date: 1988-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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