STAT PROFILE PLUS 9 ANALYZER— 510(k) K936066

Name: FDA 510(k) clearance K936066
Creator: U.S. Food and Drug Administration
Published: 1995-03-09

Substantially Equivalent

Nova Biomedical Corp.

FDA 510(k) clearance K936066 for STAT PROFILE PLUS 9 ANALYZER, Substantially Equivalent on 1995-03-09. Applicant: Nova Biomedical Corp.. Device class: 1.

Clearance details

Applicant: Nova Biomedical Corp.
Product code: Code KHP
Device class: Class 1
Regulation: 21 CFR 862.1450
Advisory panel: Clinical Chemistry
Date received: 1993-12-21
Decision date: 1995-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

Download summary PDF View on FDA.gov ↗

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