CAPILLARYS NEONAT HB (PN 2006)— 510(k) K091283

Substantially Equivalent

Sebia

FDA 510(k) clearance K091283 for CAPILLARYS NEONAT HB (PN 2006), Substantially Equivalent on 2010-02-22. Applicant: Sebia.

Clearance details

Applicant: Sebia
Product code: Code GKA
Advisory panel: Hematology
Date received: 2009-05-01
Decision date: 2010-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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