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510(k) K984067

STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK by Dade Behring, Inc. — Product Code JHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1999
Date Received
November 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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Other clearances for product code JHX

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  • K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II (August 17, 2009)
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  • K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY (July 21, 2004)
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  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
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