The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Aca Plus Luteinizing Hormone (lh) Method.
| Device ID | K943996 |
| 510k Number | K943996 |
| Device Name: | DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | DUPONT MEDICAL PRODUCTS 331 TREBLE COVE RD. N. Billerica, MA 01862 |
| Contact | Rebrcca Ayash |
| Correspondent | Rebrcca Ayash DUPONT MEDICAL PRODUCTS 331 TREBLE COVE RD. N. Billerica, MA 01862 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1994-10-20 |