The following data is part of a premarket notification filed by Becton Dickinson Diagnostic Instrument Systems with the FDA for Qbc Accutube.
| Device ID | K953340 |
| 510k Number | K953340 |
| Device Name: | QBC ACCUTUBE |
| Classification | Counter, Differential Cell |
| Applicant | BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Contact | Dennis Mertz |
| Correspondent | Dennis Mertz 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 | 1995-07-17 |
| Decision Date | 1995-10-05 |