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510(k) K982298

OPTICOAT T4 EIA KIT by Biotecx Laboratories, Inc. — Product Code KLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1999
Date Received
July 1, 1998
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 Biotecx Laboratories, Inc.

  • K981824 — OPTICOAT T3 EIA KIT (December 22, 1998)
  • K895407 — CORTISOL CLASP-BEAD EIA KIT (October 19, 1989)
  • K893620 — T3 CLASP-BEAD EIA KIT (August 11, 1989)
  • K892853 — T4 CLASP-BEAD EIA KIT (May 22, 1989)
  • K883765 — TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE (October 31, 1988)
  • K871211 — PROGESTERONE CLASP RADIOIMMUNOASSAY KIT (April 13, 1987)
  • K863188 — HPL RIA KIT (September 25, 1986)
  • K854876 — ALDOSTERONE DIRECT RIA KIT (March 17, 1986)
  • K851540 — ESTRADIOL DIRECT RIA KIT (June 6, 1985)
  • K844767 — RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (February 1, 1985)

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  • K082638 — ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL (February 26, 2009)
  • K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (August 22, 2003)
  • K023369 — ACCESS TOTAL T4 ASSAY (December 9, 2002)
  • K001603 — REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) (October 5, 2000)
  • K000600 — SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS (March 27, 2000)
  • K991432 — BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 (June 2, 1999)
  • K983440 — ABBOTT ARCHITECT TOTAL T4 (November 25, 1998)