MILES URINE UREA NITROGEN METHOD— 510(k) K923035

Name: FDA 510(k) clearance K923035
Creator: U.S. Food and Drug Administration
Published: 1992-09-09

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K923035 for MILES URINE UREA NITROGEN METHOD, Substantially Equivalent on 1992-09-09. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1992-06-19
Decision date: 1992-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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