CARDIAC TROPONIN-I (TROP) CALIBRATOR— 510(k) K973668

Substantially Equivalent

Dade Intl., Inc.

FDA 510(k) clearance K973668 for CARDIAC TROPONIN-I (TROP) CALIBRATOR, Substantially Equivalent on 1997-10-20. Applicant: Dade Intl., Inc..

Clearance details

Applicant: Dade Intl., Inc.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 1997-09-25
Decision date: 1997-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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