CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN— 510(k) K901123

Name: FDA 510(k) clearance K901123
Creator: U.S. Food and Drug Administration
Published: 1990-05-10

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K901123 for CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN, Substantially Equivalent on 1990-05-10. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1990-03-12
Decision date: 1990-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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