COLORIMETRIC BUN— 510(k) K831414

Name: FDA 510(k) clearance K831414
Creator: U.S. Food and Drug Administration
Published: 1983-06-16

Substantially Equivalent

Bio-Analytics Laboratories, Inc.

FDA 510(k) clearance K831414 for COLORIMETRIC BUN, Substantially Equivalent on 1983-06-16. Applicant: Bio-Analytics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Analytics Laboratories, Inc.
Product code: Code CDL
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1983-05-02
Decision date: 1983-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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