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510(k) K830769

FEKAL CON-TRATE SYSTEM by Trend Scientific, Inc. — Product Code KLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1983
Date Received
March 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

Other clearances by Trend Scientific, Inc.

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  • K952467 — TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) (November 20, 1995)
  • K953284 — TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM (October 6, 1995)
  • K862914 — FEKAL CHECK PARASITOLOGY CONTROL SLIDE (September 16, 1986)

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  • K982298 — OPTICOAT T4 EIA KIT (February 3, 1999)