GEMENI URIC ACID U.V.— 510(k) K873358

Name: FDA 510(k) clearance K873358
Creator: U.S. Food and Drug Administration
Published: 1987-09-11

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K873358 for GEMENI URIC ACID U.V., Substantially Equivalent on 1987-09-11. Applicant: Electro-Nucleonics Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code CDO
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1987-08-21
Decision date: 1987-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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