Cleared Traditional

URS-1B (BLOOD TEST)

K023297 · Teco Diagnostics · Chemistry
Mar 2003
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K023297 is an FDA 510(k) clearance for the URS-1B (BLOOD TEST), a Blood, Occult, Colorimetric, In Urine (Class II — Special Controls, product code JIO), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on March 6, 2003, 155 days after receiving the submission on October 2, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K023297 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2002
Decision Date March 06, 2003
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIO — Blood, Occult, Colorimetric, In Urine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6550

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