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510(k) K852343

DIG RADIOIMMUNOASSAY TEST SYSTEM by M Nobird, Inc. — Product Code DNL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1985
Date Received
June 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances for product code DNL

  • K852291 — TIPSEP DIGOXIN RIA (June 25, 1985)
  • K811212 — DIGOXIN (RIA) KIT (May 21, 1981)
  • K810966 — DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (April 21, 1981)
  • K802841 — DIGOXIN RADIOIMMUNOASSAY KIT (December 18, 1980)
  • K781834 — TEST SET, 125 I-DIGOXIN (January 3, 1979)
  • K781495 — RIANEN ASSAY SYSTEM, 125I KIT (September 14, 1978)
  • K772110 — IN VITRO DIGOXIN RIA TEST (November 22, 1977)