The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Methods For The Dimension Clinical Chem. System.
| Device ID | K862955 |
| 510k Number | K862955 |
| Device Name: | METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Grace H Singles |
| Correspondent | Grace H Singles E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | KLS |
| Subsequent Product Code | DIP |
| Subsequent Product Code | DLZ |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-05 |
| Decision Date | 1986-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596006 | K862955 | 000 |
| 00842768005664 | K862955 | 000 |