Cleared Traditional

AMNIOTEST(TM)

K914419 · Pro-Lab, Inc. · Chemistry
Sep 1993
Decision
699d
Days
Class 1
Risk

About This 510(k) Submission

K914419 is an FDA 510(k) clearance for the AMNIOTEST(TM), a Sampler, Amniotic Fluid (amniocentesis Tray) (Class I — General Controls, product code HIO), submitted by Pro-Lab, Inc. (Ontario Canada M5m 1c9, CA). The FDA issued a Cleared decision on September 1, 1993, 699 days after receiving the submission on October 3, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 884.1550.

Submission Details

510(k) Number K914419 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 1991
Decision Date September 01, 1993
Days to Decision 699 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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