Cleared Traditional

FETAL BLOOD SAMPLING KIT #1560

K831459 · Transidyne General Corp. · Obstetrics & Gynecology
Jun 1983
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K831459 is an FDA 510(k) clearance for the FETAL BLOOD SAMPLING KIT #1560, a Sampler, Blood, Fetal (Class II — Special Controls, product code HGW), submitted by Transidyne General Corp. (Walker, US). The FDA issued a Cleared decision on June 30, 1983, 55 days after receiving the submission on May 6, 1983. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1560.

Submission Details

510(k) Number K831459 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1983
Decision Date June 30, 1983
Days to Decision 55 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HGW — Sampler, Blood, Fetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1560