PREDICTA ERYTHROPOIETIN KIT— 510(k) K926390

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K926390 for PREDICTA ERYTHROPOIETIN KIT, Substantially Equivalent on 1993-06-25. Applicant: Genzyme Corp.. Device class: 2.

Clearance details

Applicant: Genzyme Corp.
Product code: Code GGT
Device class: Class 2
Regulation: 21 CFR 864.7250
Advisory panel: Hematology
Date received: 1992-12-22
Decision date: 1993-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, 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.