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510(k) K012789

MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 by Morax — Product Code JHO

K012789 is an FDA 510(k) premarket notification submitted by Morax for the device "MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123". The FDA issued a decision of Substantially Equivalent on January 17, 2002. The device falls under product code JHO (Electrophoretic Separation, Lipoproteins), 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
January 17, 2002
Date Received
August 20, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic Separation, Lipoproteins
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)
  • 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)
  • K990250 — HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P (June 18, 1999)
  • K981048 — HYDRAGEL 6 CSF KIT (October 7, 1998)
  • K974854 — HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KI (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 JHO

  • K022333 — SPIFE LIPPOROTEIN-12, MODEL 3344 (August 15, 2002)
  • K022053 — HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 (July 12, 2002)
  • K013662 — MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (March 8, 2002)
  • K013466 — SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 (December 21, 2001)
  • K010337 — LIPOPRINT SYSTEM, LDL SUBFRACTIONS (July 25, 2001)
  • K000603 — SPIFE CHOLESTEROL PROFILE KIT (April 17, 2000)
  • K992971 — REP CHOLESTEROL PROFILE KIT (October 18, 1999)
  • K974854 — HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KI (October 7, 1998)
  • K980650 — REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL (May 1, 1998)
  • K971157 — MACRALP(A) ENZYME IMMUNOASSAY KIT (April 15, 1998)

FDA data resources