ABBOTT VISION HEMOGLOBIN (MODIFICATION)— 510(k) K953221

Name: FDA 510(k) clearance K953221
Creator: U.S. Food and Drug Administration
Published: 1995-09-29

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K953221 for ABBOTT VISION HEMOGLOBIN (MODIFICATION), Substantially Equivalent on 1995-09-29. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1995-06-19
Decision date: 1995-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.