Morax: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Morax” (first 1996, latest 2003), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 169 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 3 | 3 |
| JHO | Electrophoretic Separation, Lipoproteins | 2 | 2 |
| LBT | Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl | 2 | 2 |
| CEF | Electrophoretic, Protein Fractionation | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 1 | 1 |
| JKM | Immunochemical, Bence-Jones Protein | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Immunology (4)
- Hematology (2)
Most recent Morax 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033277 | HYDRAGEL CSF ISOFOCUSING KITS | CFF | 2003-11-04 | 25 |
| K012789 | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 | JHO | 2002-01-17 | 150 |
| K992148 | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT | CGS | 1999-12-29 | 188 |
| K991362 | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) | JBD | 1999-06-21 | 68 |
| 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 | LBT | 1999-06-18 | 143 |
| K981048 | HYDRAGEL 6 CSF KIT | CFF | 1998-10-07 | 201 |
| K974854 | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 | JHO | 1998-10-07 | 282 |
| K972591 | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT | JKM | 1998-03-04 | 236 |
| K972015 | HYDRAGEL 7,15,30, CHOL-HDL KIT | LBT | 1997-10-27 | 150 |
| K963844 | HYDRAGEL 15 HB A1C KIT | LCP | 1997-04-22 | 209 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Morax.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Morax?
FDA lists 12 510(k) clearances under the applicant name “Morax” (first 1996, latest 2003), across 8 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Morax?
The median time from FDA receipt to decision across 510(k)s cleared under the name Morax is 169 days.
Which FDA product codes appear under Morax?
The most frequent FDA product codes under this applicant name are CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M), 3); JHO (Electrophoretic Separation, Lipoproteins, 2); LBT (Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl, 2).
Next steps
- See all 12 Morax clearances with predicates and recalls
- Run predicate analysis for product code CFF, Morax's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.