The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Aca Star.
| Device ID | K941050 |
| 510k Number | K941050 |
| Device Name: | DUPONT ACA STAR |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | DUPONT MEDICAL PRODUCTS ROUTE 896 Glasgow, DE 19702 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DUPONT MEDICAL PRODUCTS ROUTE 896 Glasgow, DE 19702 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-07 |
| Decision Date | 1994-11-10 |