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510(k) K802461

ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT by Immunotech Corp. — Product Code LCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digitoxin (125-I)
Device Class
Class II
Regulation Number
862.3300
Review Panel
TX
Submission Type

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Other clearances for product code LCW

  • K834080 — MATCHED COMPONENT SET FOR DIGITOXIN (February 4, 1984)
  • K780766 — (125 I) DIGITOXIN RIA KIT (July 27, 1978)