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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

K894366 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187". The FDA issued a decision of Substantially Equivalent on August 31, 1989. The device falls under product code LBT (Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl), a Class I device regulated under 21 CFR 862.1475. Helena Laboratories has at least 10 other 510(k) clearances on record.

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

Other clearances by Helena Laboratories

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  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL (October 7, 2013)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S (July 6, 2006)
  • K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (May 10, 2006)
  • K050053 — HEMORAM/AGGRAM ANALYZER (July 11, 2005)
  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
  • K023761 — PLATELETWORKS, MODELS PW-A, PW-C (February 14, 2003)

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)
  • 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)

FDA data resources