Cleared Traditional

BIOTEL (TM)/UTI

K855238 · American Diagnostic Corp. · Chemistry
May 1986
Decision
129d
Days
Class 1
Risk

About This 510(k) Submission

K855238 is an FDA 510(k) clearance for the BIOTEL (TM)/UTI, a Diazo (colorimetric), Nitrite (urinary, Non-quant) (Class I — General Controls, product code JMT), submitted by American Diagnostic Corp. (Wheaton, US). The FDA issued a Cleared decision on May 9, 1986, 129 days after receiving the submission on December 31, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1510.

Submission Details

510(k) Number K855238 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1985
Decision Date May 09, 1986
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JMT — Diazo (colorimetric), Nitrite (urinary, Non-quant)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1510

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