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510(k) K810477

DCA DIGOX-SYN RIA TEST by Diagnostic Corp. of America — Product Code DOG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1981
Date Received
February 23, 1981
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 Diagnostic Corp. of America

  • K781150 — RIA TSH IN HUMAN SERUM OR PLASMA (July 27, 1978)
  • K780412 — TOTAL IRON BINDING CAPACITY (May 26, 1978)

Other clearances for product code DOG

  • K803045 — IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. (December 22, 1980)
  • K781335 — DIGOXIN RIA (PEG) KIT (August 31, 1978)
  • K760709 — EMIT DIGOKIN ASSAY (October 21, 1976)
  • K760416 — DATA-TOPE SYSTEM DIGOXIN RIA (August 23, 1976)