TRIGLYCERIDE CALIBRATOR— 510(k) K822852

Substantially Equivalent

Harleco Diagnostics

FDA 510(k) clearance K822852 for TRIGLYCERIDE CALIBRATOR, Substantially Equivalent on 1982-10-27. Applicant: Harleco Diagnostics. Device class: 2.

Clearance details

Applicant: Harleco Diagnostics
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1982-09-24
Decision date: 1982-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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