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510(k) K792640

FLUOROMATIC PHENYTOIN FIA by Bio-Rad — Product Code DLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1980
Date Received
December 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

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Other clearances for product code DLP

  • K894527 — FPR PHENYTOIN KIT (September 25, 1989)
  • K811775 — KALLESTAD ANTISERA TO PHENYTOIN (July 10, 1981)
  • K791896 — CENTRIA PHENYTOIN RIA TEST SET (October 17, 1979)
  • K770779 — PHENYTOIN RIA KIT (June 17, 1977)