Cleared Traditional

TECO MICROALBUMIN 2-1 COMBO STRIPS

K061419 · Teco Diagnostics · Chemistry
Jan 2007
Decision
249d
Days
Class 1
Risk

About This 510(k) Submission

K061419 is an FDA 510(k) clearance for the TECO MICROALBUMIN 2-1 COMBO STRIPS, a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIR), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on January 26, 2007, 249 days after receiving the submission on May 22, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number K061419 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2006
Decision Date January 26, 2007
Days to Decision 249 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIR — Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1645

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