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510(k) K882686

ERYTHROPOIETIN ENZYME IMMUNOASSAY by Amgen, Inc. — Product Code GGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1988
Date Received
June 30, 1988
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.

  • K894943 — CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 (October 10, 1989)

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  • 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)