EPO-TRAC BY RADIOIMMUNOASSAY (RIA)— 510(k) K893393

Name: FDA 510(k) clearance K893393
Creator: U.S. Food and Drug Administration
Published: 1989-11-21

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K893393 for EPO-TRAC BY RADIOIMMUNOASSAY (RIA), Substantially Equivalent on 1989-11-21. Applicant: Incstar Corp.. Device class: 2.

Clearance details

Applicant: Incstar Corp.
Product code: Code GGT
Device class: Class 2
Regulation: 21 CFR 864.7250
Advisory panel: Hematology
Date received: 1989-05-01
Decision date: 1989-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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