GLYCOHEMOGLOBIN— 510(k) K931183

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K931183 for GLYCOHEMOGLOBIN, Substantially Equivalent on 1993-11-05. 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: 1993-03-09
Decision date: 1993-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, 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.