STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES— 510(k) K903698

Name: FDA 510(k) clearance K903698
Creator: U.S. Food and Drug Administration
Published: 1990-09-17

Substantially Equivalent

Statspin Technologies

FDA 510(k) clearance K903698 for STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES, Substantially Equivalent on 1990-09-17. Applicant: Statspin Technologies. Device class: 2.

Clearance details

Applicant: Statspin Technologies
Product code: Code JPI
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1990-08-15
Decision date: 1990-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, 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.