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510(k) K904035

REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM by Helena Laboratories — Product Code LBT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1990
Date Received
August 31, 1990
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)
  • K894366 — REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 (August 31, 1989)
  • K882368 — REP HDL ELECTROPHORESIS METHOD (August 8, 1988)
  • K873547 — TITAN GEL HDL CHOLESTEROL KIT (October 2, 1987)
  • K790791 — ELECTROPHORESIS REAGENT SET, HDL (June 15, 1979)