Cleared Traditional

CARAWAY TUBES, HEPARIN AND PLAIN

K881262 · Helps Products, Inc. · Hematology
May 1988
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K881262 is an FDA 510(k) clearance for the CARAWAY TUBES, HEPARIN AND PLAIN, a Tube, Collection, Capillary Blood (Class I — General Controls, product code GIO), submitted by Helps Products, Inc. (Orlando, US). The FDA issued a Cleared decision on May 6, 1988, 43 days after receiving the submission on March 24, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6150.

Submission Details

510(k) Number K881262 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1988
Decision Date May 06, 1988
Days to Decision 43 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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