The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Qbc Star Centrifugal Hematology System.
Device ID | K992849 |
510k Number | K992849 |
Device Name: | QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM |
Classification | Counter, Differential Cell |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
Contact | Monica E Giguere |
Correspondent | Monica E Giguere BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-24 |
Decision Date | 1999-09-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00858092006727 | K992849 | 000 |
00858092006017 | K992849 | 000 |
00858092006055 | K992849 | 000 |
00858092006291 | K992849 | 000 |
00858092006376 | K992849 | 000 |
00858092006550 | K992849 | 000 |
00858092006567 | K992849 | 000 |
00858092006628 | K992849 | 000 |
00858092006642 | K992849 | 000 |
00858092006659 | K992849 | 000 |
00858092006710 | K992849 | 000 |
00858092006000 | K992849 | 000 |