The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Clay Adams Qbc Centrifugal Hemotology.
Device ID | K813033 |
510k Number | K813033 |
Device Name: | CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY |
Classification | Centrifuge, Hematocrit |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
Product Code | GKG |
CFR Regulation Number | 864.6400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-28 |
Decision Date | 1982-04-09 |