The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Du Pont Analyst Analytical Test Rotor:chem-14,cali.
| Device ID | K901017 |
| 510k Number | K901017 |
| Device Name: | DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI |
| Classification | Catalytic Methods, Amylase |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Richard M Vaught |
| Correspondent | Richard M Vaught E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-05 |
| Decision Date | 1990-05-15 |