Morax
Chelsea, MI, US
Morax appears in FDA device records in Chelsea, MI. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Morax between 1996 and 2002. The busiest year on record is 1998, with 3. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 3 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012789 | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 | JHO | Substantially Equivalent | |
| K992148 | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT | CGS | Substantially Equivalent | |
| K991362 | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) | JBD | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K981048 | HYDRAGEL 6 CSF KIT | CFF | Substantially Equivalent | |
| K974854 | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 | JHO | Substantially Equivalent | |
| K972591 | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT | JKM | Substantially Equivalent | |
| K972015 | HYDRAGEL 7,15,30, CHOL-HDL KIT | LBT | Substantially Equivalent | |
| K963844 | HYDRAGEL 15 HB A1C KIT | LCP | Substantially Equivalent | |
| K960029 | HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT | CEF | Substantially Equivalent | |
| K960669 | HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS | CFF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LCPAssay, Glycosylated Hemoglobin
- LBTElectrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
- JHOElectrophoretic Separation, Lipoproteins
- CEFElectrophoretic, Protein Fractionation
- JKMImmunochemical, Bence-Jones Protein
- CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- JBDSystem, Analysis, Electrophoretic Hemoglobin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain