STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS— 510(k) K981425

Substantially Equivalent

Nova Biomedical Corp.

FDA 510(k) clearance K981425 for STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS, Substantially Equivalent on 1998-05-12. Applicant: Nova Biomedical Corp..

Clearance details

Applicant: Nova Biomedical Corp.
Product code: Code GKF
Advisory panel: Hematology
Date received: 1998-04-16
Decision date: 1998-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

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