Total Protein or TP

FDA 510(k) K971524 · Carolina Liquid Chemistries Corp.

Substantially Equivalent

510(k) numberK971524

Submission

Device name
Total Protein or TP
Applicant
Carolina Liquid Chemistries Corp.
Brea, CA, US
Received
April 28, 1997
Decision date
May 16, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K943004Total Protein QvetCEK · Traditional Prisma Systems12/09/1994SE

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Questions and answers

When was Total Protein or TP cleared by the FDA?

Total Protein or TP (K971524) received a 510(k) decision of Substantially Equivalent on May 16, 1997, 18 days after the submission was received.

What is the product code of K971524?

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