The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Du Pont Total Protein/albumin Calibrator.
| Device ID | K914917 |
| 510k Number | K914917 |
| Device Name: | DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-04 |
| Decision Date | 1991-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005091 | K914917 | 000 |