Home / 510(k) Clearances / K000600

510(k) K000600

SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS by Syva Co., Dade Behring, Inc. — Product Code KLI

K000600 is an FDA 510(k) premarket notification submitted by Syva Co., Dade Behring, Inc. for the device "SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS". The FDA issued a decision of Substantially Equivalent on March 27, 2000. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Syva Co., Dade Behring, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2000
Date Received
February 23, 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 Syva Co., Dade Behring, Inc.

  • K011920 — EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 (July 2, 2001)
  • K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 (June 18, 2001)
  • K011605 — EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 (June 12, 2001)
  • K011300 — EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 (May 17, 2001)
  • K011306 — EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 (May 16, 2001)
  • K011161 — MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 (May 15, 2001)
  • K011289 — EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 (May 15, 2001)
  • K011163 — MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 (May 10, 2001)
  • K011164 — MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 (May 10, 2001)
  • K011166 — MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 (May 10, 2001)

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)
  • K001603 — REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) (October 5, 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