CRITSPIN MICRO-HEMATOCRIT— 510(k) K920759

Name: FDA 510(k) clearance K920759
Creator: U.S. Food and Drug Administration
Published: 1992-04-29

Substantially Equivalent

Stat-Spin Technologies

FDA 510(k) clearance K920759 for CRITSPIN MICRO-HEMATOCRIT, Substantially Equivalent on 1992-04-29. Applicant: Stat-Spin Technologies. Device class: 2.

Clearance details

Applicant: Stat-Spin Technologies
Product code: Code GKG
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1992-02-19
Decision date: 1992-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, US

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K925863 — SPUNCRIT1993-02-05
K920207 — HERMLE Z230H1992-06-09

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