GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL— 510(k) K000239

Name: FDA 510(k) clearance K000239
Creator: U.S. Food and Drug Administration
Published: 2000-03-21

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K000239 for GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL, Substantially Equivalent on 2000-03-21. Applicant: Genzyme Corp.. Device class: 2.

Clearance details

Applicant: Genzyme Corp.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2000-01-27
Decision date: 2000-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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