Cleared Traditional

MEGA AMNIOCENTESIS KIT

K915863 · Mega Medical, Inc. · Obstetrics & Gynecology
Mar 1992
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K915863 is an FDA 510(k) clearance for the MEGA AMNIOCENTESIS KIT, a Sampler, Amniotic Fluid (amniocentesis Tray) (Class I — General Controls, product code HIO), submitted by Mega Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on March 30, 1992, 90 days after receiving the submission on December 31, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1550.

Submission Details

510(k) Number K915863 FDA.gov
FDA Decision Cleared SEKD
Date Received December 31, 1991
Decision Date March 30, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HIO — Sampler, Amniotic Fluid (amniocentesis Tray)
Device Class Class I — General Controls
CFR Regulation 21 CFR 884.1550

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