The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dimension Ar Clinical Chemistry System.
| Device ID | K915106 |
| 510k Number | K915106 |
| Device Name: | DIMENSION AR CLINICAL CHEMISTRY SYSTEM |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | DUPONT MEDICAL PRODUCTS DIAGNOSTICS & BIOTECHNOLOGY SYSTEMS DIVISION Wilmington, DE 19880 |
| Contact | Carolyn K.george |
| Correspondent | Carolyn K.george DUPONT MEDICAL PRODUCTS DIAGNOSTICS & BIOTECHNOLOGY SYSTEMS DIVISION Wilmington, DE 19880 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1992-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005909 | K915106 | 000 |
| 00842768005886 | K915106 | 000 |