1570 - FETAL BLOOD SAMPLING KIT— 510(k) K891388

Name: FDA 510(k) clearance K891388
Creator: U.S. Food and Drug Administration
Published: 1989-03-28

Substantially Equivalent

Transidyne General Corp.

FDA 510(k) clearance K891388 for 1570 - FETAL BLOOD SAMPLING KIT, Substantially Equivalent on 1989-03-28. 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: 1989-03-14
Decision date: 1989-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGW

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K884685 — ROCKET FETAL BLOOD SAMPLING TRAY1989-01-12
K831459 — FETAL BLOOD SAMPLING KIT #15601983-06-30
K810028 — FETAL BLOOD SAMPLING KIT MODEL 15601981-01-16

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K950449 — SURGICAL BUR1995-03-01

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