NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER— 510(k) K863438

Name: FDA 510(k) clearance K863438
Creator: U.S. Food and Drug Administration
Published: 1986-09-29

Substantially Equivalent

Nova Biomedical Corp.

FDA 510(k) clearance K863438 for NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER, Substantially Equivalent on 1986-09-29. Applicant: Nova Biomedical Corp.. Device class: 1.

Clearance details

Applicant: Nova Biomedical Corp.
Product code: Code JJP
Device class: Class 1
Regulation: 21 CFR 862.2050
Advisory panel: Clinical Chemistry
Date received: 1986-09-05
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

Download summary PDF View on FDA.gov ↗

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