SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST— 510(k) K022409

Substantially Equivalent

Spectral Diagnostics, Inc.

FDA 510(k) clearance K022409 for SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST, Substantially Equivalent on 2002-09-30. Applicant: Spectral Diagnostics, Inc..

Clearance details

Applicant
Spectral Diagnostics, Inc.
Product code
Code JHT
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Toronto, Ontario, CA
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