CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)— 510(k) K981474

Substantially Equivalent

Spectral Diagnostics, Inc.

FDA 510(k) clearance K981474 for CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I), Substantially Equivalent on 1998-05-07. Applicant: Spectral Diagnostics, Inc..

Clearance details

Applicant: Spectral Diagnostics, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1998-04-24
Decision date: 1998-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

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