HEMOCHEK SAMPLE COLLECTION KIT— 510(k) K984529

Name: FDA 510(k) clearance K984529
Creator: U.S. Food and Drug Administration
Published: 1999-01-28

Substantially Equivalent

Osborn Laboratories, Inc.

FDA 510(k) clearance K984529 for HEMOCHEK SAMPLE COLLECTION KIT, Substantially Equivalent on 1999-01-28. Applicant: Osborn Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Osborn Laboratories, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1998-12-21
Decision date: 1999-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Olathe, KS, US

Download summary PDF View on FDA.gov ↗

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