Cleared Traditional

QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM

K972969 · Innovative Medical Technologies, Inc. · Hematology
Sep 1997
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K972969 is an FDA 510(k) clearance for the QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM, a Tube, Collection, Capillary Blood (Class I — General Controls, product code GIO), submitted by Innovative Medical Technologies, Inc. (Lenexa, US). The FDA issued a Cleared decision on September 22, 1997, 42 days after receiving the submission on August 11, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6150.

Submission Details

510(k) Number K972969 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1997
Decision Date September 22, 1997
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GIO — Tube, Collection, Capillary Blood
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.6150

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