DeviceClearance

HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801— 510(k) K061047

Substantially Equivalent

Hemocue AB

FDA 510(k) clearance K061047 for HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801, Substantially Equivalent on 2006-06-08. Applicant: Hemocue AB.

Clearance details

Applicant
Hemocue AB
Product code
Code GKR
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Forest, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.