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510(k) K903492

DSL ERYTHROPOIETIN (DSL # 1100) by Diagnostic Systems Laboratories, Inc. — Product Code GGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
August 3, 1990
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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  • K990138 — DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (June 21, 1999)
  • K981871 — C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 (November 9, 1998)
  • K973243 — ACTIVE PSA ELISA (DSL-10-9700) (August 3, 1998)
  • K973244 — ACTIVE PSA IRMA (DSL-9700) (August 3, 1998)
  • K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (May 27, 1998)

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  • 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)