ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT— 510(k) K983172

Name: FDA 510(k) clearance K983172
Creator: U.S. Food and Drug Administration
Published: 1998-11-30

Substantially Equivalent

Diabetes Technologies, Inc. (Dti)

FDA 510(k) clearance K983172 for ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT, Substantially Equivalent on 1998-11-30. Applicant: Diabetes Technologies, Inc. (Dti). Device class: 2.

Clearance details

Applicant: Diabetes Technologies, Inc. (Dti)
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1998-09-10
Decision date: 1998-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thomasville, GA, US

Download summary PDF View on FDA.gov ↗

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