Total Proteins

FDA 510(k) K850936 · Dilab, Inc.

Substantially Equivalent

510(k) numberK850936

Submission

Device name
Total Proteins
Applicant
Dilab, Inc.
Miami, FL, US
Received
March 7, 1985
Decision date
June 25, 1985
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
K862530Rapid AS LatexGTQ · Traditional 04/21/1987SE
K850931AlbuminCIX · Traditional 06/26/1985SE
K850938CholesterolCGO · Traditional 06/25/1985SE
K850934PhosphorusCEO · Traditional 06/25/1985SE
K850933Uric AcidCDH · Traditional 06/25/1985SE
K850932CreatinineCGX · Traditional 06/25/1985SE
K850937UreaCDW · Traditional 06/10/1985SE
K850935ChlorideCHJ · Traditional 06/10/1985SE
K850930GlucoseCGE · Traditional 06/10/1985SE
K850929CalciumCIC · Traditional 06/10/1985SE

Questions and answers

When was Total Proteins cleared by the FDA?

Total Proteins (K850936) received a 510(k) decision of Substantially Equivalent on June 25, 1985, 110 days after the submission was received.

What is the product code of K850936?

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