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510(k) K834080

MATCHED COMPONENT SET FOR DIGITOXIN by Cambridge Medical Technology — Product Code LCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
November 28, 1983
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

  • K802461 — ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT (October 31, 1980)
  • K780766 — (125 I) DIGITOXIN RIA KIT (July 27, 1978)