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510(k) K990250

HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 by Morax — Product Code LBT

K990250 is an FDA 510(k) premarket notification submitted by Morax for the device "HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0". The FDA issued a decision of Substantially Equivalent on June 18, 1999. The device falls under product code LBT (Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl), a Class I device regulated under 21 CFR 862.1475. Morax has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1999
Date Received
January 26, 1999
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 Morax

  • K033277 — HYDRAGEL CSF ISOFOCUSING KITS (November 4, 2003)
  • K012789 — MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 (January 17, 2002)
  • K992148 — HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL I (December 29, 1999)
  • K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), A (June 21, 1999)
  • K974854 — HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KI (October 7, 1998)
  • K981048 — HYDRAGEL 6 CSF KIT (October 7, 1998)
  • K972591 — HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES (March 4, 1998)
  • K972015 — HYDRAGEL 7,15,30, CHOL-HDL KIT (October 27, 1997)
  • K963844 — HYDRAGEL 15 HB A1C KIT (April 22, 1997)
  • K960029 — HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT (July 17, 1996)

Other clearances for product code LBT

  • K000568 — HDL CHOLESTEROL PLUS (August 4, 2000)
  • 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)
  • K790791 — ELECTROPHORESIS REAGENT SET, HDL (June 15, 1979)

FDA data resources