GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL— 510(k) K983726

Name: FDA 510(k) clearance K983726
Creator: U.S. Food and Drug Administration
Published: 1998-11-25

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K983726 for GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL, Substantially Equivalent on 1998-11-25. 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: 1998-10-22
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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