Cleared Traditional

1570 - FETAL BLOOD SAMPLING KIT

K891388 · Transidyne General Corp. · Obstetrics & Gynecology

Mar 1989

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K891388 is an FDA 510(k) clearance for the 1570 - FETAL BLOOD SAMPLING KIT, a Sampler, Blood, Fetal (Class II — Special Controls, product code HGW), submitted by Transidyne General Corp. (Ann Arbor, US). The FDA issued a Cleared decision on March 28, 1989, 14 days after receiving the submission on March 14, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1560.

Submission Details

510(k) Number	K891388 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 1989
Decision Date	March 28, 1989
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—