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  1. Substantially Equivalent 510(k) Device Information

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
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