The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Dimension (tm) Clinical Chemistry System.
| Device ID | K861700 |
| 510k Number | K861700 |
| Device Name: | DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Grace Singles |
| Correspondent | Grace Singles E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | CHH |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CJW |
| Subsequent Product Code | JGJ |
| Subsequent Product Code | JHS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JQB |
| Subsequent Product Code | LBS |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-05 |
| Decision Date | 1986-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005343 | K861700 | 000 |
| 00842768004995 | K861700 | 000 |
| 00842768004957 | K861700 | 000 |
| 00842768014154 | K861700 | 000 |
| 00842768005466 | K861700 | 000 |
| 00842768014185 | K861700 | 000 |