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510(k) K972591

HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT by Morax — Product Code JKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1998
Date Received
July 11, 1997
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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  • K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), A (June 21, 1999)
  • K990250 — HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P (June 18, 1999)
  • K974854 — HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KI (October 7, 1998)
  • K981048 — HYDRAGEL 6 CSF KIT (October 7, 1998)
  • K972015 — HYDRAGEL 7,15,30, CHOL-HDL KIT (October 27, 1997)
  • K963844 — HYDRAGEL 15 HB A1C KIT (April 22, 1997)
  • K960029 — HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT (July 17, 1996)

Other clearances for product code JKM

  • K080916 — CAPILLARYS URINE (July 1, 2008)
  • K070486 — CAPILLARYS URINE (PN 2012) (December 21, 2007)
  • K050119 — PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY S (May 6, 2005)