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510(k) K021229

MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 by Beckman Coulter, Inc. — Product Code DDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2002
Date Received
April 18, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Myoglobin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5680
Review Panel
IM
Submission Type

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  • K042924 — ARCHITECT STAT MYO IMMUNOASSAY (January 24, 2005)
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  • K012040 — RAMP MYOGLOBIN ASSAY (December 18, 2001)