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510(k) K050119

PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT by Beckman Coulter, Inc. — Product Code JKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2005
Date Received
January 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunochemical, Bence-Jones Protein
Device Class
Class II
Regulation Number
866.5150
Review Panel
IM
Submission Type

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Other clearances for product code JKM

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