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510(k) K080916

CAPILLARYS URINE by Sebia — Product Code JKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2008
Date Received
April 2, 2008
Clearance Type
Special
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

  • K070486 — CAPILLARYS URINE (PN 2012) (December 21, 2007)
  • K050119 — PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY S (May 6, 2005)
  • K972591 — HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES (March 4, 1998)