BIOTEL (TM)/ DIABETES— 510(k) K855239

Name: FDA 510(k) clearance K855239
Creator: U.S. Food and Drug Administration
Published: 1986-06-13

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K855239 for BIOTEL (TM)/ DIABETES, Substantially Equivalent on 1986-06-13. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1985-12-31
Decision date: 1986-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheaton, IL, US

Download summary PDF View on FDA.gov ↗

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