Cleared Traditional

BLOOD PH CAPILLARY TUBES, HEPARIN

K881188 · Helps Products, Inc. · Chemistry
Jul 1988
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K881188 is an FDA 510(k) clearance for the BLOOD PH CAPILLARY TUBES, HEPARIN, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Helps Products, Inc. (Orlando, US). The FDA issued a Cleared decision on July 8, 1988, 109 days after receiving the submission on March 21, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K881188 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1988
Decision Date July 08, 1988
Days to Decision 109 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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