Cleared Traditional

TOTAL PROTEIN TEST (TPRO)

K935174 · Em Diagnostic Systems, Inc. · Chemistry
Dec 1993
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K935174 is an FDA 510(k) clearance for the TOTAL PROTEIN TEST (TPRO), a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 16, 1993, 50 days after receiving the submission on October 27, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K935174 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1993
Decision Date December 16, 1993
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CEK — Biuret (colorimetric), Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635

Similar Devices — CEK Biuret (colorimetric), Total Protein

All 115
HICHEM TOTAL PROTEIN REAGENT
K992846 · Elan Holdings, Inc. · Oct 1999
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
K973108 · Diagnostic Chemicals , Ltd. · Mar 1998
CARESIDE TOTAL PROTEIN
K980042 · Exigent Diagnostics, Inc. · Feb 1998
TOTAL PROTEIN OR TP
K971524 · Carolina Liquid Chemistries Corp. · May 1997
CSF/URINE TOTAL PROTEIN
K961864 · Teco Diagnostics · Oct 1996
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
K955905 · Solarcare Technologies Corp,Inc. · May 1996