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510(k) K780766

(125 I) DIGITOXIN RIA KIT by Diagnostic Products Corp. — Product Code LCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
May 5, 1978
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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  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code LCW

  • K834080 — MATCHED COMPONENT SET FOR DIGITOXIN (February 4, 1984)
  • K802461 — ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT (October 31, 1980)