The following data is part of a premarket notification filed by Becton Dickinson Diagnostic Instrument Systems with the FDA for Qbc Accuread System.
| Device ID | K955504 |
| 510k Number | K955504 |
| Device Name: | QBC ACCUREAD SYSTEM |
| Classification | Counter, Differential Cell |
| Applicant | BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Contact | Rocky Ganske |
| Correspondent | Rocky Ganske BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Product Code | GKZ |
| Subsequent Product Code | GIO |
| Subsequent Product Code | GKG |
| Subsequent Product Code | JKA |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-01 |
| Decision Date | 1996-02-05 |