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510(k) K001603

REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) by Repromedix Corp. — Product Code KLI

K001603 is an FDA 510(k) premarket notification submitted by Repromedix Corp. for the device "REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)". The FDA issued a decision of Substantially Equivalent on October 5, 2000. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Repromedix Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2000
Date Received
May 24, 2000
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 Repromedix Corp.

  • K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (October 5, 2000)
  • K001606 — REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) (October 5, 2000)

Other clearances for product code KLI

  • K160495 — VITROS® Automation Solutions (October 18, 2016)
  • K131515 — ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (August 14, 2013)
  • K103484 — GSP NEONATAL THYROXINE (T4) (April 22, 2011)
  • 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)
  • K000600 — SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS (March 27, 2000)
  • K991432 — BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 (June 2, 1999)
  • K982298 — OPTICOAT T4 EIA KIT (February 3, 1999)
  • K983440 — ABBOTT ARCHITECT TOTAL T4 (November 25, 1998)

FDA data resources