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510(k) K914833

IMMULITE DIGOXIN by Cirrus Diagnostics, Inc. — Product Code DPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1991
Date Received
October 25, 1991
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

Other clearances by Cirrus Diagnostics, Inc.

  • K921704 — IMMULITE(R) FSH (June 9, 1992)
  • K920411 — IMMULITE HLH (March 11, 1992)
  • K911796 — IMMULITE(TM) HCG (June 20, 1991)
  • K910677 — IMMULITE(TM) T-UPTAKE (April 29, 1991)
  • K910261 — IMMULITE(TM) TOTAL T4 (April 16, 1991)
  • K905648 — CRP LIPID REAGENT TEST PACK (March 6, 1991)
  • K905214 — IMMULITE (TM) TOTAL T3 (February 1, 1991)
  • K905769 — IMMULITE HS-TSH (January 31, 1991)
  • K905215 — IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER (January 11, 1991)

Other clearances for product code DPO

  • 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)
  • K832163 — SOPHEIA DIGOXIN EIA KIT (August 12, 1983)
  • 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)