HEMOCUE B-HEMOGLOBIN SYSTEM— 510(k) K961312

Substantially Equivalent

Hemocue, Inc.

FDA 510(k) clearance K961312 for HEMOCUE B-HEMOGLOBIN SYSTEM, Substantially Equivalent on 1996-09-24. Applicant: Hemocue, Inc..

Clearance details

Applicant: Hemocue, Inc.
Product code: Code GKR
Advisory panel: Hematology
Date received: 1996-04-04
Decision date: 1996-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

Download summary PDF View on FDA.gov ↗

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