BIOTEL (TM)/UTI— 510(k) K855238

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K855238 for BIOTEL (TM)/UTI, Substantially Equivalent on 1986-05-09. Applicant: American Diagnostic Corp.. Device class: 1.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code JMT
Device class: Class 1
Regulation: 21 CFR 862.1510
Advisory panel: Clinical Chemistry
Date received: 1985-12-31
Decision date: 1986-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheaton, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.