FDA 510(k) Premarket Notification K102064: BD FACS SAMPLE PREP ASSISTANT III (SPA III)

Submission Details & Decision

Normalized public record details for 510(k) notification K102064.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K102064

Applicant / Sponsor

Becton, Dickinson & CO

Device Name

BD FACS SAMPLE PREP ASSISTANT III (SPA III)

Product Code

GKZ

Decision Date

2011-03-07

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Hematology (HE)

Clearance Type

Traditional

Third Party Flag

Date Received

2010-07-23

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