Sodium Reagent Set

FDA 510(k) K914039 · Sterling Diagnostics, Inc.

Substantially Equivalent

510(k) numberK914039

Submission

Device name
Sodium Reagent Set
Applicant
Sterling Diagnostics, Inc.
Sterling Heights, MI, US
Received
September 10, 1991
Decision date
October 31, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CEI – Uranyl Acetate/Zinc Acetate, Sodium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1665
Specialty
Clinical Chemistry

Other 510(k)s with product code CEI

510(k)DeviceApplicantDecision
K043268Sodium Test Kit and Eletrolyte Cal 1 and 2CEI · Traditional Randox Laboratories, Ltd.02/15/2005SE
K902572Sodium Reagent SetCEI · Traditional Tech Intl. Co.07/10/1990SE
K832552Sodium Test KitCEI · Traditional Mallinckrodt Critical Care09/20/1983SE

More from Mallinckrodt Critical Care

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K862255Lactate Dehydrogenase (LDH) Reagent Set (UV Rate)CFJ · Traditional 07/29/1986SE
K861962Vanilmandelic Acid (Vma) Reagent SetCDF · Traditional 07/07/1986SE
K862256Alkaline Phosphatase (PNPP Rate) Reagent SetCJE · Traditional 07/01/1986SE
K862210Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional 07/01/1986SE
K862209Alt (SGPT) Reagent Set (UV Rate)CKA · Traditional 06/25/1986SE
K861855Hydroxybutyrate Dehydrogenase (HBD) Reagent SetJKF · Traditional 06/16/1986SE
K861713Serum Potassium Reagent SetCEJ · Traditional 05/23/1986SE

Questions and answers

When was Sodium Reagent Set cleared by the FDA?

Sodium Reagent Set (K914039) received a 510(k) decision of Substantially Equivalent on October 31, 1991, 51 days after the submission was received.

What is the product code of K914039?

The FDA product code is CEI – Uranyl Acetate/Zinc Acetate, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.