STA - CONTROL LA 1+2— 510(k) K061803

Substantially Equivalent

Diagnostica Stago, Inc.

FDA 510(k) clearance K061803 for STA - CONTROL LA 1+2, Substantially Equivalent on 2006-07-28. Applicant: Diagnostica Stago, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostica Stago, Inc.
Product code: Code GGC
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2006-06-27
Decision date: 2006-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parisppany, NJ, 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.