MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT— 510(k) K897133

Name: FDA 510(k) clearance K897133
Creator: U.S. Food and Drug Administration
Published: 1990-03-30

Substantially Equivalent

Transidyne General Corp.

FDA 510(k) clearance K897133 for MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT, Substantially Equivalent on 1990-03-30. Applicant: Transidyne General Corp.. Device class: 1.

Clearance details

Applicant: Transidyne General Corp.
Product code: Code CBT
Device class: Class 1
Regulation: 21 CFR 868.1100
Advisory panel: Anesthesiology
Date received: 1989-12-27
Decision date: 1990-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, 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.