The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Du Pont Legionella Urinary Antigen - Ria Kit.
| Device ID | K871328 |
| 510k Number | K871328 |
| Device Name: | DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT |
| Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Edward R Kimmelman |
| Correspondent | Edward R Kimmelman E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | LHL |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-03 |
| Decision Date | 1987-09-02 |