Company ยท US
Morax
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2003. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 3 |
| JHO | Electrophoretic Separation, Lipoproteins | 2 |
| LBT | Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl | 2 |
| CEF | Electrophoretic, Protein Fractionation | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 1 |
| JKM | Immunochemical, Bence-Jones Protein | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 4, 2003 | K033277 | HYDRAGEL CSF ISOFOCUSING KITS Morax | CFF |
| Jan 17, 2002 | K012789 | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 Morax | JHO |
| Dec 29, 1999 | K992148 | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT Morax | CGS |
| Jun 21, 1999 | K991362 | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) Morax | JBD |
| Jun 18, 1999 | 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 Morax | LBT |
| Oct 7, 1998 | K981048 | HYDRAGEL 6 CSF KIT Morax | CFF |
| Oct 7, 1998 | K974854 | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 Morax | JHO |
| Mar 4, 1998 | K972591 | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT Morax | JKM |
| Oct 27, 1997 | K972015 | HYDRAGEL 7,15,30, CHOL-HDL KIT Morax | LBT |
| Apr 22, 1997 | K963844 | HYDRAGEL 15 HB A1C KIT Morax | LCP |
| Jul 17, 1996 | K960029 | HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT Morax | CEF |
| Jul 12, 1996 | K960669 | HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS Morax | CFF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||