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510(k) K030815

AKERS LABORATORIES INC. BLOOD CELL SEPARATOR by Akers Laboratories, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2003
Date Received
March 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Akers Laboratories, Inc.

  • K040293 — HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY (May 28, 2004)
  • K031579 — INSTAREAD LITHIUM SYSTEM (December 19, 2003)

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