ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT— 510(k) K013465

Name: FDA 510(k) clearance K013465
Creator: U.S. Food and Drug Administration
Published: 2002-01-22

Substantially Equivalent

Diabetes Technologies, Inc.

FDA 510(k) clearance K013465 for ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT, Substantially Equivalent on 2002-01-22. Applicant: Diabetes Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Diabetes Technologies, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2001-10-18
Decision date: 2002-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thomasville, GA, US

Download summary PDF View on FDA.gov ↗

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