GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.— 510(k) K802432

Name: FDA 510(k) clearance K802432
Creator: U.S. Food and Drug Administration
Published: 1980-12-01

Substantially Equivalent

Clin Tech Diagnostics Corp.

FDA 510(k) clearance K802432 for GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT., Substantially Equivalent on 1980-12-01. Applicant: Clin Tech Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Clin Tech Diagnostics Corp.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1980-10-06
Decision date: 1980-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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