TECO MICROALBUMIN 2-1 COMBO STRIPS— 510(k) K061419

Name: FDA 510(k) clearance K061419
Creator: U.S. Food and Drug Administration
Published: 2007-01-26

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K061419 for TECO MICROALBUMIN 2-1 COMBO STRIPS, Substantially Equivalent on 2007-01-26. Applicant: Teco Diagnostics. Device class: 1.

Clearance details

Applicant: Teco Diagnostics
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 2006-05-22
Decision date: 2007-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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