Vaccines, Blood & Biologics

Cleared 510(k) Submissions with Supporting Documents - 2018

This list includes cleared 510(k) submissions for 2018 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) NumberApplicantDevice NameDecision Date
Minneapolis, MN
Neg Control2/2/2018
BK170142bioMerieux, Inc.
Hazelwood, MO
BacT/ALERT BPA Culture Bottle; BacT/ALERT BPN Culture Bottle2/1/2018
BK170138Ethicon Inc.
Somerville, NJ
EVICEL™ Laparoscopic Airless Spray Accessory (35cm Rigid)1/26/2018
BK170141Helmer Inc.
Noblesville, IN
UltraCW®II Automatic Cell Washing System1/22/2018
BK170162Grifols Diagnostic Solutions, Inc.Procleix Xpress® System (Software v3.0)1/18/2018


Page Last Updated: 02/12/2018
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