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510(k) K935162

REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT by Helena Laboratories — Product Code JHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1994
Date Received
October 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic Separation, Lipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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Other clearances for product code JHO

  • K022333 — SPIFE LIPPOROTEIN-12, MODEL 3344 (August 15, 2002)
  • K022053 — HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 (July 12, 2002)
  • K013662 — MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (March 8, 2002)
  • K012789 — MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 (January 17, 2002)
  • K013466 — SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 (December 21, 2001)
  • K010337 — LIPOPRINT SYSTEM, LDL SUBFRACTIONS (July 25, 2001)
  • K000603 — SPIFE CHOLESTEROL PROFILE KIT (April 17, 2000)
  • K992971 — REP CHOLESTEROL PROFILE KIT (October 18, 1999)
  • K974854 — HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KI (October 7, 1998)
  • K980650 — REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL (May 1, 1998)