MDX 2000, DIGITAL ANALYZER— 510(k) K970824

Name: FDA 510(k) clearance K970824
Creator: U.S. Food and Drug Administration
Published: 1997-05-30

Substantially Equivalent

Shotwell & Carr, Inc.

FDA 510(k) clearance K970824 for MDX 2000, DIGITAL ANALYZER, Substantially Equivalent on 1997-05-30. Applicant: Shotwell & Carr, Inc.. Device class: 2.

Clearance details

Applicant: Shotwell & Carr, Inc.
Product code: Code JOY
Device class: Class 2
Regulation: 21 CFR 864.5260
Advisory panel: Hematology
Date received: 1997-03-06
Decision date: 1997-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, 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.