Protein Test for Urine and CSF

FDA 510(k) K900733 · Elite Technology, Inc.

Substantially Equivalent

510(k) numberK900733

Submission

Device name
Protein Test for Urine and CSF
Applicant
Elite Technology, Inc.
Canada M9w 5p1, CA
Received
February 16, 1990
Decision date
July 10, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CEK – Biuret (Colorimetric), Total Protein
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1635
Specialty
Clinical Chemistry

Other 510(k)s with product code CEK

510(k)DeviceApplicantDecision
K992846Hichem Total Protein ReagentCEK · Traditional Elan Holdings, Inc.10/18/1999SE
K973108Total Protein (Micro) Assay, Catalogue Number 450-50CEK · Traditional Diagnostic Chemicals , Ltd.03/02/1998SE
K980042Careside Total ProteinCEK · Traditional Exigent Diagnostics, Inc.02/04/1998SE
K971524Total Protein or TPCEK · Traditional Carolina Liquid Chemistries Corp.05/16/1997SE
K961864Csf/Urine Total ProteinCEK · Traditional Teco Diagnostics10/24/1996SE
K955905STC Diagnostics Auto-Lyte Urinary Protein AssayCEK · Traditional Solarcare Technologies Corp,Inc.05/30/1996SE
K955936Total Protein ReagentCEK · Traditional Derma Media Lab., Inc.03/12/1996SE
K950920Dupont Dimension Total Protein MethodCEK · Traditional Dupont Medical Products08/11/1995SE
K950234Total Protein Test (Tpro) Item Number: XXXXX/R1. R2CEK · Traditional Emd Chemicals, Inc.06/14/1995SE
K950128Total Protein Test (Tpro) Item XXXXX/R1. R2CEK · Traditional Emd Chemicals, Inc.05/15/1995SE

More from Emd Chemicals, Inc.

510(k)DeviceDecision
K901001Uric Acid Test KitKNK · Traditional 05/23/1990SE
K901090Elitech Gamma GT Test KitJPZ · Traditional 03/29/1990SE
K895951Cholesterol Test KitCHH · Traditional 02/16/1990SE
K895952Triglycerides Test KitCDT · Traditional 01/11/1990SE

Questions and answers

When was Protein Test for Urine and CSF cleared by the FDA?

Protein Test for Urine and CSF (K900733) received a 510(k) decision of Substantially Equivalent on July 10, 1990, 144 days after the submission was received.

What is the product code of K900733?

The FDA product code is CEK – Biuret (Colorimetric), Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.