ERYTHROPOIETIN ENZYME IMMUNOASSAY— 510(k) K882686

Substantially Equivalent

Amgen, Inc.

FDA 510(k) clearance K882686 for ERYTHROPOIETIN ENZYME IMMUNOASSAY, Substantially Equivalent on 1988-12-20. Applicant: Amgen, Inc.. Device class: 2.

Clearance details

Applicant: Amgen, Inc.
Product code: Code GGT
Device class: Class 2
Regulation: 21 CFR 864.7250
Advisory panel: Hematology
Date received: 1988-06-30
Decision date: 1988-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, 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.