The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Control Sera Level Values (mg/dl).
| Device ID | K861567 |
| 510k Number | K861567 |
| Device Name: | CONTROL SERA LEVEL VALUES (MG/DL) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | R. M Vaught |
| Correspondent | R. M Vaught E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-28 |
| Decision Date | 1986-05-23 |