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510(k) K070486

CAPILLARYS URINE (PN 2012) by Sebia, Inc. — Product Code JKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2007
Date Received
February 20, 2007
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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  • K203184 — HYDRASHIFT 2/4 isatuximab (November 12, 2021)
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  • K180762 — CAPI 3 HEMOGLOBIN(E) (December 14, 2018)
  • K171861 — CAPILLARYS Hb A1c (February 7, 2018)
  • K172195 — HYDRASHIFT 2/4 daratumumab, daratumumab Control (January 11, 2018)
  • K171537 — CAPI 3 Hb A1c (September 12, 2017)

Other clearances for product code JKM

  • K080916 — CAPILLARYS URINE (July 1, 2008)
  • 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)