Medical Device Manufacturer · US , Chelsea , MI

Morax

12 submissions · 12 cleared · Since 1996
12
Total
12
Cleared
0
Denied

Morax — FDA 510(k) Submissions

Morax has submitted 12 FDA 510(k) premarket notifications since 1996, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Immunoelectrophoretic, Immunoglobulins, (g, A, M), Electrophoretic Separation, Lipoproteins, Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl, Electrophoretic, Protein Fractionation, Assay, Glycosylated Hemoglobin . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
HYDRAGEL CSF ISOFOCUSING KITS
K033277 · CFF Immunoelectrophoretic,... · Immunology
Nov 2003 25d
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
K012789 · JHO Electrophoretic... · Chemistry
Jan 2002 150d
HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT
K992148 · CGS Nad Reduction/nadh... · Chemistry
Dec 1999 188d
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
K991362 · JBD System, Analysis,... · Hematology
Jun 1999 68d
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
K990250 · LBT Electrophoresis,... · Chemistry
Jun 1999 143d
HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207
K974854 · JHO Electrophoretic... · Chemistry
Oct 1998 282d
HYDRAGEL 6 CSF KIT
K981048 · CFF Immunoelectrophoretic,... · Immunology
Oct 1998 201d
HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT
K972591 · JKM Immunochemical,... · Immunology
Mar 1998 236d
HYDRAGEL 7,15,30, CHOL-HDL KIT
K972015 · LBT Electrophoresis,... · Chemistry
Oct 1997 150d
HYDRAGEL 15 HB A1C KIT
K963844 · LCP Assay, Glycosylated... · Hematology
Apr 1997 209d
HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT
K960029 · CEF Electrophoretic, Protein... · Chemistry
Jul 1996 197d
HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS
K960669 · CFF Immunoelectrophoretic,... · Immunology
Jul 1996 143d
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