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510(k) K905719

ECLIPSE ICA DIGOXIN by Biotope, Inc. — Product Code DPO

K905719 is an FDA 510(k) premarket notification submitted by Biotope, Inc. for the device "ECLIPSE ICA DIGOXIN". The FDA issued a decision of Substantially Equivalent on January 17, 1991. 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. Biotope, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1991
Date Received
December 21, 1990
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 Biotope, Inc.

  • K905145 — ECLIPSE ICA CHOLESTEROL (February 26, 1991)
  • K910256 — ECLIPSE ICA TSH (February 22, 1991)
  • K910302 — ECLIPSE ICA ANALYZER (February 22, 1991)
  • K905601 — ECLIPSE ICA TRIGLYCERIDES (January 17, 1991)
  • K905602 — ECLIPSE ICA BUN (January 16, 1991)
  • K905144 — ECLIPSE ICA GLUCOSE (January 4, 1991)

Other clearances for product code DPO

  • K914833 — IMMULITE DIGOXIN (November 22, 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)

FDA data resources