UREA NITROGEN (BUN) LIQUID REAGENT— 510(k) K011596

Name: FDA 510(k) clearance K011596
Creator: U.S. Food and Drug Administration
Published: 2001-07-17

Substantially Equivalent

Jas Diagnostic, Inc.

FDA 510(k) clearance K011596 for UREA NITROGEN (BUN) LIQUID REAGENT, Substantially Equivalent on 2001-07-17. Applicant: Jas Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Jas Diagnostic, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 2001-05-24
Decision date: 2001-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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