The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Aca Plus Ferritin Calibrator.
| Device ID | K935543 |
| 510k Number | K935543 |
| Device Name: | ACA PLUS FERRITIN CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. Wilmington, DE 19898 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash E.I. DUPONT DE NEMOURS & CO., INC. 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 | 1993-11-16 |
| Decision Date | 1994-03-22 |