UREA NITROGEN(BUN), COLORIMETRIC METHOD— 510(k) K864742

Name: FDA 510(k) clearance K864742
Creator: U.S. Food and Drug Administration
Published: 1987-01-13

Substantially Equivalent

Tech-Co, Inc.

FDA 510(k) clearance K864742 for UREA NITROGEN(BUN), COLORIMETRIC METHOD, Substantially Equivalent on 1987-01-13. Applicant: Tech-Co, Inc.. Device class: 2.

Clearance details

Applicant: Tech-Co, Inc.
Product code: Code CDL
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1986-12-04
Decision date: 1987-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, US

Download summary PDF View on FDA.gov ↗

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