QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)— 510(k) K936016

Name: FDA 510(k) clearance K936016
Creator: U.S. Food and Drug Administration
Published: 1994-07-19

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K936016 for QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA), Substantially Equivalent on 1994-07-19. Applicant: R&D Systems, Inc.. Device class: 2.

Clearance details

Applicant: R&D Systems, Inc.
Product code: Code GGT
Device class: Class 2
Regulation: 21 CFR 864.7250
Advisory panel: Hematology
Date received: 1993-12-16
Decision date: 1994-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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