CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST— 510(k) K883327

Name: FDA 510(k) clearance K883327
Creator: U.S. Food and Drug Administration
Published: 1989-01-23

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K883327 for CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST, Substantially Equivalent on 1989-01-23. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code JGZ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1988-08-08
Decision date: 1989-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

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