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 |