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510(k) K944063

FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE by Sigma Diagnostics, Inc. — Product Code LGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1994
Date Received
August 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Carbamazepine
Device Class
Class II
Regulation Number
862.3645
Review Panel
TX
Submission Type

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Other clearances for product code LGI

  • K940682 — AXSYM(TM) QUINIDINE (June 21, 1994)
  • K900702 — MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (April 12, 1990)