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510(k) K240182

Access EPO by Beckman Coulter, Inc. — Product Code GGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2024
Date Received
January 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Erythropoietin
Device Class
Class II
Regulation Number
864.7250
Review Panel
HE
Submission Type

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Other clearances for product code GGT

  • K183088 — ADVIA Centaur Erythropoietin (EPO) assay (August 2, 2019)
  • K052223 — ACCESS EPO ASSAY (October 6, 2006)
  • K992799 — SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT (June 7, 2000)
  • K983203 — IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 (July 12, 1999)
  • K980737 — ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY (March 23, 1999)
  • K952559 — ERYTHROPOIETIN IMMUNOASSAY KIT (May 29, 1996)
  • K954898 — PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) (February 5, 1996)
  • K936016 — QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (July 19, 1994)
  • K931756 — QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS (April 21, 1994)
  • K932650 — ERYTHROPOIETIN IMMUNOASSAY KIT (March 11, 1994)