DeviceClearance

STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.— 510(k) K051650

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K051650 for STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK., Substantially Equivalent on 2005-09-08. Applicant: Dade Behring, Inc..

Clearance details

Applicant
Dade Behring, Inc.
Product code
Code JHX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newark, DE, US
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