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510(k) K882368

REP HDL ELECTROPHORESIS METHOD by Helena Laboratories — Product Code LBT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1988
Date Received
June 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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Other clearances for product code LBT

  • K000568 — HDL CHOLESTEROL PLUS (August 4, 2000)
  • K990250 — HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P (June 18, 1999)
  • K972015 — HYDRAGEL 7,15,30, CHOL-HDL KIT (October 27, 1997)
  • K904035 — REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM (November 9, 1990)
  • K894366 — REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 (August 31, 1989)
  • K873547 — TITAN GEL HDL CHOLESTEROL KIT (October 2, 1987)
  • K790791 — ELECTROPHORESIS REAGENT SET, HDL (June 15, 1979)