510(k) K222299

Steripath Micro Blood Collection System by Magnolia Medical Technologies — Product Code JKA

K222299 is an FDA 510(k) premarket notification submitted by Magnolia Medical Technologies for the device "Steripath Micro Blood Collection System". The FDA issued a decision of Substantially Equivalent on November 30, 2022. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Magnolia Medical Technologies has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2022
Date Received
August 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type