NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3— 510(k) K962997

Name: FDA 510(k) clearance K962997
Creator: U.S. Food and Drug Administration
Published: 1996-08-15

Substantially Equivalent

Nova Biomedical Corp.

FDA 510(k) clearance K962997 for NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3, Substantially Equivalent on 1996-08-15. Applicant: Nova Biomedical Corp.. Device class: 1.

Clearance details

Applicant: Nova Biomedical Corp.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1996-08-02
Decision date: 1996-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

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