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510(k) K803045

IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. by American Dade — Product Code DOG

K803045 is an FDA 510(k) premarket notification submitted by American Dade for the device "IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.". The FDA issued a decision of Substantially Equivalent on December 22, 1980. The device falls under product code DOG (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol), a Class II device regulated under 21 CFR 862.3320. American Dade has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1980
Date Received
December 1, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by American Dade

  • K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY (October 20, 1987)
  • K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (September 29, 1987)
  • K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY (September 14, 1987)
  • K872789 — PARAMAX URINE/CSF CALIBRATOR (September 2, 1987)
  • K872195 — DATA-FI DIMERTEST LATEX ASSAY (August 6, 1987)
  • K872196 — AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III (July 31, 1987)
  • K871972 — STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (July 21, 1987)
  • K871977 — DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (July 9, 1987)
  • K872050 — PARAMAX CHOLESTEROL REAGENT (July 7, 1987)
  • K872360 — DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (July 6, 1987)

Other clearances for product code DOG

  • K810477 — DCA DIGOX-SYN RIA TEST (March 11, 1981)
  • K781335 — DIGOXIN RIA (PEG) KIT (August 31, 1978)
  • K760709 — EMIT DIGOKIN ASSAY (October 21, 1976)
  • K760416 — DATA-TOPE SYSTEM DIGOXIN RIA (August 23, 1976)

FDA data resources