CELL-DYN 22 PLUS CALIBRATOR— 510(k) K111204

Substantially Equivalent

Streck

FDA 510(k) clearance K111204 for CELL-DYN 22 PLUS CALIBRATOR, Substantially Equivalent on 2011-12-22. Applicant: Streck. Device class: 2.

Clearance details

Applicant: Streck
Product code: Code KRX
Device class: Class 2
Regulation: 21 CFR 864.8150
Advisory panel: Hematology
Date received: 2011-04-29
Decision date: 2011-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, 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.