Cleared Traditional

FETAL BLOOD SAMPLING KIT MODEL 1560

K810028 · Transidyne General Corp. · Obstetrics & Gynecology
Jan 1981
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K810028 is an FDA 510(k) clearance for the FETAL BLOOD SAMPLING KIT MODEL 1560, a Sampler, Blood, Fetal (Class II — Special Controls, product code HGW), submitted by Transidyne General Corp. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1981, 10 days after receiving the submission on January 6, 1981. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1560.

Submission Details

510(k) Number K810028 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1981
Decision Date January 16, 1981
Days to Decision 10 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