ENI BLOOD UREA NITROGEN REAGENT— 510(k) K844065

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K844065 for ENI BLOOD UREA NITROGEN REAGENT, Substantially Equivalent on 1984-11-27. Applicant: Electro-Nucleonics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant
Electro-Nucleonics Laboratories, Inc.
Product code
Code CDQ
Device class
Class 2
Regulation
21 CFR 862.1770
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Columbia, MD, US
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