EZCHEK/HBA BLOOD COLLECTION KIT— 510(k) K971919

Name: FDA 510(k) clearance K971919
Creator: U.S. Food and Drug Administration
Published: 1997-09-05

Substantially Equivalent

Flexsite Diagnostics, Inc.

FDA 510(k) clearance K971919 for EZCHEK/HBA BLOOD COLLECTION KIT, Substantially Equivalent on 1997-09-05. Applicant: Flexsite Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Flexsite Diagnostics, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1997-05-23
Decision date: 1997-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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