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510(k) K894366

REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 by Helena Laboratories — Product Code LBT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1989
Date Received
July 14, 1989
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

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  • K972015 — HYDRAGEL 7,15,30, CHOL-HDL KIT (October 27, 1997)
  • K904035 — REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM (November 9, 1990)
  • 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)