The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Automated Cell-washing Centrifuge For Immune-hematology.
Device ID | BK130032 |
510k Number | BK130032 |
Device Name: | Automated Cell-washing Centrifuge For Immune-hematology |
Classification | Centrifuge, Cell-washing, Automated For Immuno-hematology |
Applicant | Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 Raritan, NJ 08869 US |
Product Code | KSN |
CFR Regulation Number | 864.9285 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-01 |
Decision Date | 2013-08-09 |