BIOTEL (TM)/ KIDNEY— 510(k) K855237

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K855237 for BIOTEL (TM)/ KIDNEY, Substantially Equivalent on 1986-05-06. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1985-12-31
Decision date: 1986-05-06
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.