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510(k) K893620

T3 CLASP-BEAD EIA KIT by Biotecx Laboratories, Inc. — Product Code CDP

K893620 is an FDA 510(k) premarket notification submitted by Biotecx Laboratories, Inc. for the device "T3 CLASP-BEAD EIA KIT". The FDA issued a decision of Substantially Equivalent on August 11, 1989. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Biotecx Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1989
Date Received
May 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Triiodothyronine
Device Class
Class II
Regulation Number
862.1710
Review Panel
CH
Submission Type

Other clearances by Biotecx Laboratories, Inc.

  • K982298 — OPTICOAT T4 EIA KIT (February 3, 1999)
  • K981824 — OPTICOAT T3 EIA KIT (December 22, 1998)
  • K895407 — CORTISOL CLASP-BEAD EIA KIT (October 19, 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)

Other clearances for product code CDP

  • K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (October 5, 2000)
  • K991692 — CHIRON DIAGNOSTICS ACS: 180 FT3 (June 18, 1999)
  • K991311 — TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 (June 2, 1999)
  • K991252 — AIA-PACK FT3 ASSAY (May 11, 1999)
  • K981824 — OPTICOAT T3 EIA KIT (December 22, 1998)
  • K983434 — ABBOTT ARCHITECT TOTAL T3 (November 20, 1998)
  • K983439 — ABBOTT ARCHITECT FREE T3 (November 20, 1998)
  • K974027 — AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK (February 2, 1998)
  • K974634 — IMMULITE FREE T3 (January 2, 1998)
  • K973966 — ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (October 31, 1997)

FDA data resources