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510(k) K864449

DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT by Canadian Bioclinical, Ltd. — Product Code DPO

K864449 is an FDA 510(k) premarket notification submitted by Canadian Bioclinical, Ltd. for the device "DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on February 2, 1987. The device falls under product code DPO (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.), a Class II device regulated under 21 CFR 862.3320. Canadian Bioclinical, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1987
Date Received
November 12, 1986
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 Canadian Bioclinical, Ltd.

  • K933794 — ANI BIOCARD(TM) HCG TEST (May 19, 1994)
  • K870968 — TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (June 22, 1987)
  • K870969 — CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (June 22, 1987)

Other clearances for product code DPO

  • K914833 — IMMULITE DIGOXIN (November 22, 1991)
  • K905719 — ECLIPSE ICA DIGOXIN (January 17, 1991)
  • 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)

FDA data resources