510(k) K013711

BACTI-SWAB DRY by Remel Co. — Product Code LIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2001
Date Received
November 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type