GLYCO-CHECK— 510(k) K852111

Substantially Equivalent

Thyroid Diagnostics, Inc.

FDA 510(k) clearance K852111 for GLYCO-CHECK, Substantially Equivalent on 1985-07-05. Applicant: Thyroid Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Thyroid Diagnostics, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1985-05-15
Decision date: 1985-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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