HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)— 510(k) K895585

Name: FDA 510(k) clearance K895585
Creator: U.S. Food and Drug Administration
Published: 1989-11-13

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K895585 for HI CHEM TRIGLYCERIDES CALIBRATOR E (88185), Substantially Equivalent on 1989-11-13. Applicant: Hichem Diagnostics. Device class: 2.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1989-09-15
Decision date: 1989-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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