The following data is part of a premarket notification filed by Becton Dickinson Diagnostic Instrument Systems with the FDA for Qbc Accutube(423406)/qbc Autoread(424571).
| Device ID | K960827 |
| 510k Number | K960827 |
| Device Name: | QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) |
| 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 |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-29 |
| Decision Date | 1996-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858092006604 | K960827 | 000 |
| 00858092006574 | K960827 | 000 |
| 00858092006383 | K960827 | 000 |
| 00858092006260 | K960827 | 000 |
| 00858092006253 | K960827 | 000 |
| 00858092006086 | K960827 | 000 |
| 00858092006079 | K960827 | 000 |
| 00858092006048 | K960827 | 000 |
| 00858092006024 | K960827 | 000 |