The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Meth./cali./intru. Check For The Dimension System.
| Device ID | K862359 |
| 510k Number | K862359 |
| Device Name: | METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-23 |
| Decision Date | 1986-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005695 | K862359 | 000 |
| 00842768005626 | K862359 | 000 |
| 00842768004933 | K862359 | 000 |
| 00842768004919 | K862359 | 000 |
| 00842768033124 | K862359 | 000 |
| 00842768014192 | K862359 | 000 |