Phospholipid Reagent Set

FDA 510(k) K914040 · Sterling Diagnostics, Inc.

Substantially Equivalent

510(k) numberK914040

Submission

Device name
Phospholipid Reagent Set
Applicant
Sterling Diagnostics, Inc.
Sterling Heights, MI, US
Received
September 10, 1991
Decision date
October 30, 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
JNT – Chromatographic, Phospholipids
Device class
Class I (low risk)
Regulation
21 CFR 862.1575
Specialty
Clinical Chemistry

Other 510(k)s with product code JNT

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K922792ZithromaxJNT · Traditional Difco Laboratories, Inc.07/30/1992SE
K792349Susceptibility Disk, Cinoxacin 100 Mcg.JNT · Traditional Pfizer, Inc.03/12/1980SE

More from Pfizer, Inc.

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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 Phospholipid Reagent Set cleared by the FDA?

Phospholipid Reagent Set (K914040) received a 510(k) decision of Substantially Equivalent on October 30, 1991, 50 days after the submission was received.

What is the product code of K914040?

The FDA product code is JNT – Chromatographic, Phospholipids, a Class I (low risk) device regulated under 21 CFR 862.1575.