COULTER UREA NITROGEN REAGENT— 510(k) K902175

Substantially Equivalent

Coulter Corp.

FDA 510(k) clearance K902175 for COULTER UREA NITROGEN REAGENT, Substantially Equivalent on 1990-06-12. Applicant: Coulter Corp.. Device class: 2.

Clearance details

Applicant: Coulter Corp.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1990-05-14
Decision date: 1990-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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