BUN TEST UNI-UV BLOOD UREA NITROGEN TEST— 510(k) K780943

Name: FDA 510(k) clearance K780943
Creator: U.S. Food and Drug Administration
Published: 1978-07-27

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K780943 for BUN TEST UNI-UV BLOOD UREA NITROGEN TEST, Substantially Equivalent on 1978-07-27. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1978-06-07
Decision date: 1978-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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