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510(k) K894943

CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 by Amgen, Inc. — Product Code GGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1989
Date Received
August 3, 1989
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

Other clearances by Amgen, Inc.

  • K882686 — ERYTHROPOIETIN ENZYME IMMUNOASSAY (December 20, 1988)

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  • 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)