Cleared 510(k) Submissions with Supporting Documents - 2021
This list includes cleared 510(k) submissions for 2021 for which we have supporting documents available, and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change.
The clearances are listed by clearance date in reverse chronological order.
510(k) Number | Applicant | Device Name | Decision Date |
---|---|---|---|
BK200548 | Bio-Rad Medical Diagnostics GmbH Dreieich, Germany |
IH-1000 | 1/12/2021 |
BK200546 | One Lambda, Inc. Canoga Park, CA |
LABScreen Multi | 1/6/2021 |