The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Aca Plus Immunoassay System Follicle Stimulating Hormone.
| Device ID | K941221 |
| 510k Number | K941221 |
| Device Name: | DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 Wilmington, DE 19880 -0022 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 Wilmington, DE 19880 -0022 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1994-07-20 |