Dupont Medical Products
Wilmington, DE, US
Dupont Medical Products appears in FDA device records in Wilmington, DE. FDA records list 28 510(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
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Dupont Medical Products between 1991 and 1995. The busiest year on record is 1994, with 16. The most recent is 1995, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 5 |
| 1994 | 16 |
| 1995 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K952815 | DUPONT LIPASE CALIBRATOR | JIT | Substantially Equivalent | |
| K950920 | DUPONT DIMENSION TOTAL PROTEIN METHOD | CEK | Substantially Equivalent | |
| K952816 | LIPASE FLEX REAGENT CARTRIDGE | CHI | Substantially Equivalent | |
| K952412 | DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL | DIF | Substantially Equivalent | |
| K945280 | DUPONT DIMENSION C-REACTIVE PROTEIN METHOD | DCK | Substantially Equivalent | |
| K944932 | PHENOBARBITAL FLEX REAGENT CARTRIDGE | DLZ | Substantially Equivalent | |
| K941050 | DUPONT ACA STAR | JJQ | Substantially Equivalent | |
| K943996 | DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD | CEP | Substantially Equivalent | |
| K941146 | DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM | JLW | Substantially Equivalent | |
| K942640 | DUPONT DIMENSION AMYLASE METHOD | JFJ | Substantially Equivalent | |
| K942241 | DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN | JKA | Substantially Equivalent | |
| K942240 | DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN | JKA | Substantially Equivalent | |
| K941219 | DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR | JIX | Substantially Equivalent | |
| K943024 | KINASE ISOENZYME | JHS | Substantially Equivalent | |
| K941475 | CRONEX REGULAR CASSETTE | IXA | Substantially Equivalent | |
| K941221 | DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE | CGJ | Substantially Equivalent | |
| K941584 | CREATINE KINASE METHOD | JHS | Substantially Equivalent | |
| K941518 | DUPONT CRONEX PORTABLE GRID CASSETTE | IXA | Substantially Equivalent | |
| K941220 | DUPONT ACA PLUS PROLACTIN (PROL) METHOD | CFT | Substantially Equivalent | |
| K936202 | URINARY ALBUMIN TEST PACK | JIQ | Substantially Equivalent | |
| K936201 | URINARY ALBUMIN CALIBRATOR | JIS | Substantially Equivalent | |
| K932732 | ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN) | KXT | Substantially Equivalent | |
| K933161 | ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN | EAM | Substantially Equivalent | |
| K933648 | ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK | JZG | Substantially Equivalent | |
| K930501 | DU PONT ACA NEV/EEV VERIFIER | JIS | Substantially Equivalent | |
| K932044 | DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD | CEM | Substantially Equivalent | |
| K915106 | DIMENSION AR CLINICAL CHEMISTRY SYSTEM | JJE | Substantially Equivalent | |
| K910354 | DU PONT IDENTIFICATION CAMERA | JAC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CEKBiuret (Colorimetric), Total Protein
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- IXACassette, Radiographic Film
- JFJCatalytic Methods, Amylase
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- DIFDrug Mixture Control Materials
- CEMElectrode, Ion Specific, Potassium
- KXTEnzyme Immunoassay, Digoxin
- DLZEnzyme Immunoassay, Phenobarbital
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- EAMScreen, Intensifying, Radiographic
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- JACSystem, X-Ray, Film Marking, Radiographic
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain