ANALYZER: STAT PROFILE PLUS 10 ANALYZER— 510(k) K931373

Name: FDA 510(k) clearance K931373
Creator: U.S. Food and Drug Administration
Published: 1993-06-15

Substantially Equivalent

Nova Biomedical Corp.

FDA 510(k) clearance K931373 for ANALYZER: STAT PROFILE PLUS 10 ANALYZER, Substantially Equivalent on 1993-06-15. 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: 1993-03-18
Decision date: 1993-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

Download summary PDF View on FDA.gov ↗

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