HEMOGLOBIN A1C REAGENT SET— 510(k) K051200

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K051200 for HEMOGLOBIN A1C REAGENT SET, Substantially Equivalent on 2005-08-08. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2005-05-10
Decision date: 2005-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.