The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Analyst Physician's Office Profiler.
| Device ID | K854523 |
| 510k Number | K854523 |
| Device Name: | ANALYST PHYSICIAN'S OFFICE PROFILER |
| Classification | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Roger C Briden |
| Correspondent | Roger C Briden E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | JJG |
| CFR Regulation Number | 862.2140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1986-01-08 |