IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN— 510(k) K884075

Name: FDA 510(k) clearance K884075
Creator: U.S. Food and Drug Administration
Published: 1988-10-19

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K884075 for IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN, Substantially Equivalent on 1988-10-19. Applicant: Orion Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code DDG
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 1988-09-27
Decision date: 1988-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 02101 Espoo, FI

Download summary PDF View on FDA.gov ↗

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