STRATUS CS TROPONIN I CALIBRATOR— 510(k) K012233

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K012233 for STRATUS CS TROPONIN I CALIBRATOR, Substantially Equivalent on 2001-09-11. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2001-07-16
Decision date: 2001-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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