KLI — Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Class II
FDA product code KLI covers "Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine", a Class II medical device regulated under 21 CFR 862.1700. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLI
- Device Class
- Class II
- Regulation Number
- 862.1700
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K160495 | ortho-clinical diagnostics | VITROS® Automation Solutions | October 18, 2016 |
| K131515 | alfa wassermann | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT | August 14, 2013 |
| K103484 | wallac oy, a subsidiary of perkinelmer | GSP NEONATAL THYROXINE (T4) | April 22, 2011 |
| K082638 | siemens healthcare diagnostics | ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL | February 26, 2009 |
| K030860 | monobind | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | August 22, 2003 |
| K023369 | beckman coulter | ACCESS TOTAL T4 ASSAY | December 9, 2002 |
| K001603 | repromedix | REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) | October 5, 2000 |
| K000600 | syva co., dade behring | SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS | March 27, 2000 |
| K991432 | biocheck | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 | June 2, 1999 |
| K982298 | biotecx laboratories | OPTICOAT T4 EIA KIT | February 3, 1999 |
| K983440 | abbott laboratories | ABBOTT ARCHITECT TOTAL T4 | November 25, 1998 |
| K981377 | schiapparelli biosystems | ACE T4 REAGENT T4 CALIBRATORS | June 10, 1998 |
| K972974 | neometrics | ACCUWELL T4-EIA | October 6, 1997 |
| K971709 | monobind | TOTAL THROXINE MICROPLATE EIA(225-300) | June 16, 1997 |
| K971269 | diagnostic systems laboratories | DSL ACTIVE T4 EIA | May 22, 1997 |
| K971203 | beckman instruments | SYNCHRON SYSTEMS THYROXINE REAGENT | May 16, 1997 |
| K964721 | johnson and johnson clinical diagnostics | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALI | December 18, 1996 |
| K951014 | isolab | ISOLAB'S T4 TEST KIT | October 18, 1996 |
| K962211 | united biotech | UBI MAGIWEL THYROXINE (T4) QUANTITATIVE | July 8, 1996 |
| K953837 | biocircuits | BIOCIRCUITS IOS T4 TEST CARTRIDGE | November 20, 1995 |