The du Pont Co.
Wilmington, DE, US
The DU Pont Co. appears in FDA device records in Wilmington, DE. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for The du Pont Co. between 1988 and 1995. The busiest year on record is 1989, with 4. The most recent is 1995, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 3 |
| 1989 | 4 |
| 1990 | 1 |
| 1994 | 1 |
| 1995 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K953477 | MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING | LMC | Substantially Equivalent | |
| K953475 | CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING | LMC | Substantially Equivalent | |
| K952891 | CRONEX LOW ABSORPTION CASSETTE | IXA | Substantially Equivalent | |
| K945125 | DUPONT ACA VANCOMYCIN (VANC) METHOD | LEH | Substantially Equivalent | |
| K943704 | LIPASE CALIBRATOR | JIT | Substantially Equivalent | |
| K900492 | LABELING CHANGE - VIASPAN(TM) (BELZER UW) | KDL | Substantially Equivalent | |
| K885259 | ACA THYRONINE UPTAKE (TU E) METHOD | KHQ | Substantially Equivalent | |
| K885258 | ACA THYROXINE (T4 E) METHOD | KLI | Substantially Equivalent | |
| K884700 | ANALYST THYROXINE (T4) ROTOR | KLI | Substantially Equivalent | |
| K884169 | DU PONT ANALYST THYROID ROTOR | CEL | Substantially Equivalent | |
| K884168 | ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. | JIS | Substantially Equivalent | |
| K884170 | ANALYST THEOPHYLLINE CALIBRATOR | DLJ | Substantially Equivalent | |
| K884002 | ANALYST THEOPHYLLINE ROTOR | KLS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CELAmmonium Molybdate And Ammonium Vanadate, Phospholipids
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DLJCalibrators, Drug Specific
- LMCCamera, Multi Format, Radiological
- IXACassette, Radiographic Film
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- KLSEnzyme Immunoassay, Theophylline
- KHQRadioassay, Triiodothyronine Uptake
- LEHRadioimmunoassay, Vancomycin
- KDLSet, Perfusion, Kidney, Disposable
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
