The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Apc Blood Collection Container With Thromboplastin.
| Device ID | K942241 |
| 510k Number | K942241 |
| Device Name: | DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | DUPONT MEDICAL PRODUCTS BARLEY MILL PLAZA P22-1170 Wilmington, DE 19880 -0022 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George DUPONT MEDICAL PRODUCTS BARLEY MILL PLAZA P22-1170 Wilmington, DE 19880 -0022 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-09 |
| Decision Date | 1994-08-18 |