CO2 Reagent Set

FDA 510(k) K864313 · Hf Scientific, Inc.

Substantially Equivalent

510(k) numberK864313

Submission

Device name
CO2 Reagent Set
Applicant
Hf Scientific, Inc.
Ft. Myers, FL, US
Received
November 3, 1986
Decision date
March 13, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CIE – Volumetric/Manometric, Carbon-Dioxide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1160
Specialty
Clinical Chemistry

Other 510(k)s with product code CIE

510(k)DeviceApplicantDecision
K904761P/N 35310, Il Test Alkaline Phosphatase ReagentCIE · Traditional Instrumentation Laboratory CO11/20/1990SE
K880967Micro CO2 ApparatusCIE · Traditional Hf Scientific, Inc.04/28/1988SE
K832071Total CO2 Reagent SetCIE · Traditional American Research Products Co.08/11/1983SE
K820091Airmed Smoke Evacuation & FilterCIE · Traditional James L. Geraci & Associates, Inc.02/24/1982SE
K800524Seralyzer Reflectance Photometer/Calib.CIE · Traditional Miles Laboratories, Inc.04/02/1980SE
K771610Carbon Dioxide AnalyzerCIE · Traditional Corning Medical & Scientific10/07/1977SE

More from Corning Medical & Scientific

510(k)DeviceDecision
K882801Rinse & Reference Solution/Buffer/Low & High Stan.JGS · Traditional 08/29/1988SE
K880967Micro CO2 ApparatusCIE · Traditional 04/28/1988SE
K874429Hemoglobin Determination Test Kit HGB S-100 & 12GIQ · Traditional 02/04/1988SE
K864862Ref. Membrane for Orion 1020 Sodium/Potassium Ana.JGS · Traditional 02/20/1987SE

Questions and answers

When was CO2 Reagent Set cleared by the FDA?

CO2 Reagent Set (K864313) received a 510(k) decision of Substantially Equivalent on March 13, 1987, 130 days after the submission was received.

What is the product code of K864313?

The FDA product code is CIE – Volumetric/Manometric, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.