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510(k) K925436

MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT by Medix Biotech, Inc. — Product Code CDP

K925436 is an FDA 510(k) premarket notification submitted by Medix Biotech, Inc. for the device "MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT". The FDA issued a decision of Substantially Equivalent on December 28, 1992. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Medix Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1992
Date Received
October 28, 1992
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 Medix Biotech, Inc.

  • K952873 — MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) (September 8, 1995)
  • K952319 — CONTRAST & RAPID HCG URINE/SERUM TST (June 20, 1995)
  • K932482 — MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 (July 18, 1994)
  • K932758 — MEDIX BIOTECH BESTEST HCG-URINE TEST KIT (September 28, 1993)
  • K924259 — MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 (November 25, 1992)
  • K922047 — IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 (August 5, 1992)
  • K921700 — TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 (June 29, 1992)
  • K920712 — MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT (March 27, 1992)
  • K920345 — PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) (March 18, 1992)
  • K920299 — MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT (March 4, 1992)

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