Cleared Traditional

ROCKET FETAL BLOOD SAMPLING TRAY

K884685 · A & A Medical, Inc. · Obstetrics & Gynecology
Jan 1989
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K884685 is an FDA 510(k) clearance for the ROCKET FETAL BLOOD SAMPLING TRAY, a Sampler, Blood, Fetal (Class II — Special Controls, product code HGW), submitted by A & A Medical, Inc. (Branford, US). The FDA issued a Cleared decision on January 12, 1989, 65 days after receiving the submission on November 8, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1560.

Submission Details

510(k) Number K884685 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1988
Decision Date January 12, 1989
Days to Decision 65 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