Blood PH Capillary Tubes, Heparin

FDA 510(k) K881188 · Helps Products, Inc.

Substantially Equivalent

510(k) numberK881188

Submission

Device name
Blood PH Capillary Tubes, Heparin
Applicant
Helps Products, Inc.
Orlando, FL, US
Received
March 21, 1988
Decision date
July 8, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1120
Specialty
Clinical Chemistry

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More from Opti Medical Systems, Inc.

510(k)DeviceDecision
K881186Microhematocrit Tubes, Heparin & Microhema Tube,PlGHY · Traditional 05/13/1988SE
K881262Caraway Tubes, Heparin and PlainGIO · Traditional 05/06/1988SE
K881187Natelson Tubes, Heparin and PlainGIO · Traditional 05/06/1988SE

Questions and answers

When was Blood PH Capillary Tubes, Heparin cleared by the FDA?

Blood PH Capillary Tubes, Heparin (K881188) received a 510(k) decision of Substantially Equivalent on July 8, 1988, 109 days after the submission was received.

What is the product code of K881188?

The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.