Cleared Traditional

CAPILLARY TUBE, BLOOD COLLECTION

K885138 · Coeur Laboratories, Inc. · Hematology
Feb 1989
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K885138 is an FDA 510(k) clearance for the CAPILLARY TUBE, BLOOD COLLECTION, a Tube, Collection, Capillary Blood (Class I — General Controls, product code GIO), submitted by Coeur Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on February 7, 1989, 54 days after receiving the submission on December 15, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6150.

Submission Details

510(k) Number K885138 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1988
Decision Date February 07, 1989
Days to Decision 54 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

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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