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510(k) K222299

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

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

Other clearances by Magnolia Medical Technologies

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  • K200661 — Steripath Micro Blood Collection System (October 8, 2020)
  • K192247 — Steripath Gen2 Blood Collection System (February 28, 2020)

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