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510(k) K811776

KALLESTAD QUANTICOAT 125 DIGOXIN by Kallestad Laboratories, Inc. — Product Code DPO

K811776 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "KALLESTAD QUANTICOAT 125 DIGOXIN". The FDA issued a decision of Substantially Equivalent on July 10, 1981. 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. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
June 23, 1981
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 Kallestad Laboratories, Inc.

  • K863681 — PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM (December 3, 1986)
  • K862917 — PATHFINDER ROTAVIRUS CHEMILUMINESCENT (October 22, 1986)
  • K863682 — PATHFINDER(TM) SPECIMEN COLLECTION KIT (October 10, 1986)
  • K862743 — PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS (September 29, 1986)
  • K862313 — KALLESTAD SM/RNP TEST REAGENT (August 6, 1986)
  • K862710 — KALLESTAD SSA/SSB ENA TEST REAGENTS (July 29, 1986)
  • K855014 — QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A (March 14, 1986)
  • K855010 — QUANTIMETRIC PLUS IGM REAGENT KIT (February 28, 1986)
  • K855013 — QUANTIMETRIC PLUS SUPPORT PACK (February 26, 1986)
  • K855011 — QUANTIMETRIC PLUS C3 REAGENT KIT (February 26, 1986)

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)
  • 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)
  • 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