The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Dupont Aca Fibrin Degradation Prod Clotting Tube.
| Device ID | K852519 |
| 510k Number | K852519 |
| Device Name: | DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE |
| Classification | Bothrops Atrox Reagent |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Roger C Briden |
| Correspondent | Roger C Briden E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | JCO |
| CFR Regulation Number | 864.8100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-17 |
| Decision Date | 1985-08-12 |