UREA NITROGEN REAGENT SET (MOD. BERTHEL— 510(k) K822237

Name: FDA 510(k) clearance K822237
Creator: U.S. Food and Drug Administration
Published: 1982-08-16

Substantially Equivalent

Sterling Biochemical, Inc.

FDA 510(k) clearance K822237 for UREA NITROGEN REAGENT SET (MOD. BERTHEL, Substantially Equivalent on 1982-08-16. Applicant: Sterling Biochemical, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Biochemical, Inc.
Product code: Code CDL
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1982-07-28
Decision date: 1982-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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