RABBIT ANTI-HUMAN ANTITHROMBIN III— 510(k) K832268

Name: FDA 510(k) clearance K832268
Creator: U.S. Food and Drug Administration
Published: 1983-08-12

Substantially Equivalent

Gelco Diagnostics, Inc.

FDA 510(k) clearance K832268 for RABBIT ANTI-HUMAN ANTITHROMBIN III, Substantially Equivalent on 1983-08-12. Applicant: Gelco Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Gelco Diagnostics, Inc.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1983-06-30
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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