FETAL BLOOD SAMPLING KIT #1560— 510(k) K831459

Name: FDA 510(k) clearance K831459
Creator: U.S. Food and Drug Administration
Published: 1983-06-30

Substantially Equivalent

Transidyne General Corp.

FDA 510(k) clearance K831459 for FETAL BLOOD SAMPLING KIT #1560, Substantially Equivalent on 1983-06-30. Applicant: Transidyne General Corp.. Device class: 2.

Clearance details

Applicant: Transidyne General Corp.
Product code: Code HGW
Device class: Class 2
Regulation: 21 CFR 884.1560
Advisory panel: Obstetrics/Gynecology
Date received: 1983-05-06
Decision date: 1983-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K810028 — FETAL BLOOD SAMPLING KIT MODEL 15601981-01-16

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