EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)— 510(k) K902639

Name: FDA 510(k) clearance K902639
Creator: U.S. Food and Drug Administration
Published: 1990-08-22

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K902639 for EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA), Substantially Equivalent on 1990-08-22. 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: 1990-06-14
Decision date: 1990-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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