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510(k) K790791

ELECTROPHORESIS REAGENT SET, HDL by Gelman Sciences, Inc. — Product Code LBT

K790791 is an FDA 510(k) premarket notification submitted by Gelman Sciences, Inc. for the device "ELECTROPHORESIS REAGENT SET, HDL". The FDA issued a decision of Substantially Equivalent on June 15, 1979. The device falls under product code LBT (Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl), a Class I device regulated under 21 CFR 862.1475. Gelman Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1979
Date Received
April 24, 1979
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 Gelman Sciences, Inc.

  • K946190 — DRUG DISPENSING SPIKE (March 17, 1995)
  • K943127 — PHARMASSURE LARGE VOLUME TRANSFER FILTERS (September 29, 1994)
  • K941589 — SYRINGE FILTER DEVICES (September 6, 1994)
  • K941020 — DRUG RECONSTITUTION FILTER DEVICE (August 10, 1994)
  • K942275 — VIAL VENT FILTER (July 26, 1994)
  • K941032 — UNKNOWN (May 27, 1994)
  • K910821 — TRANSDUCER PROTECTOR (August 12, 1991)
  • K892387 — MODIFIED GELMAN ARTERIAL FILTER (June 22, 1989)
  • K884176 — CHROMATOGRAPHY KIT (April 4, 1989)
  • K884178 — DRUG CONTROL SET (February 17, 1989)

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)
  • K882368 — REP HDL ELECTROPHORESIS METHOD (August 8, 1988)
  • K873547 — TITAN GEL HDL CHOLESTEROL KIT (October 2, 1987)

FDA data resources