Cleared Traditional

HICHEM TOTAL PROTEIN REAGENT

K992846 · Elan Holdings, Inc. · Chemistry
Oct 1999
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K992846 is an FDA 510(k) clearance for the HICHEM TOTAL PROTEIN REAGENT, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on October 18, 1999, 55 days after receiving the submission on August 24, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K992846 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1999
Decision Date October 18, 1999
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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
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
TOTAL PROTEIN REAGENT
K955936 · Derma Media Lab., Inc. · Mar 1996