PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)— 510(k) K954898

Name: FDA 510(k) clearance K954898
Creator: U.S. Food and Drug Administration
Published: 1996-02-05

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K954898 for PREDICTA ERYTHROPOIETIN KIT (MODIFICATION), Substantially Equivalent on 1996-02-05. 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: 1995-09-20
Decision date: 1996-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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