DeviceClearance

SPIFE IFE CALIBRATOR AND CONTROL KIT— 510(k) K010617

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K010617 for SPIFE IFE CALIBRATOR AND CONTROL KIT, Substantially Equivalent on 2001-03-15. Applicant: Helena Laboratories.

Clearance details

Applicant
Helena Laboratories
Product code
Code DEW
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beaumont, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.