Cleared Traditional

PROTEIN TEST FOR URINE AND CSF

K900733 · Elite Technology, Inc. · Chemistry
Jul 1990
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K900733 is an FDA 510(k) clearance for the PROTEIN TEST FOR URINE AND CSF, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Elite Technology, Inc. (Canada M9w 5p1, CA). The FDA issued a Cleared decision on July 10, 1990, 144 days after receiving the submission on February 16, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K900733 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1990
Decision Date July 10, 1990
Days to Decision 144 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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