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510(k) K832163

SOPHEIA DIGOXIN EIA KIT by Diagnostic Products Corp. — Product Code DPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
July 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

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Other clearances for product code DPO

  • K914833 — IMMULITE DIGOXIN (November 22, 1991)
  • K905719 — ECLIPSE ICA DIGOXIN (January 17, 1991)
  • K864449 — DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (February 2, 1987)
  • K833842 — RIA COAT DIGOXIN (January 17, 1984)
  • K830962 — IMMUCHEM COVALENT-COAT RIA KIT (May 4, 1983)
  • K811932 — COAT-A-COUNT DIGOXIN RIA (July 23, 1981)
  • K811776 — KALLESTAD QUANTICOAT 125 DIGOXIN (July 10, 1981)
  • K800205 — RIA PHASE DIGOXIN (March 19, 1980)
  • K791325 — AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM (August 16, 1979)
  • K791355 — VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT (August 10, 1979)