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510(k) K020845

EMIT 2000 VANCOMYCIN CALIBRATORS by Dade Behring, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2002
Date Received
March 15, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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Other clearances for product code DLJ

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  • K052015 — DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (September 12, 2005)
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