Vitro T4-EIA-XT
FDA 510(k) K896865 · In Vitro Diagnostics, Inc.
510(k) numberK896865
Submission
- Device name
- Vitro T4-EIA-XT
- Applicant
- In Vitro Diagnostics, Inc.
Littleton, CO, US - Received
- December 6, 1989
- Decision date
- January 30, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1700
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KLI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160495 | VITROS® Automation SolutionsKLI · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/18/2016SE |
| K131515 | Ace -Gt Reagent; Ace Lipase Ragent; Ace T4 ReagentKLI · Traditional | Alfa Wassermann | 08/14/2013SE |
| K103484 | GSP Neonatal Thyroxine (T4)KLI · Traditional | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 04/22/2011SE |
| K082638 | Advia Centaur System with Streamlab Analytical WorkcellKLI · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/26/2009SE |
| K030860 | Accubind Neonatal T4 Microplate Eia, Model 2625-300KLI · Traditional | Monobind | 08/22/2003SE |
| K023369 | Access Total T4 AssayKLI · Traditional | Beckman Coulter, Inc. | 12/09/2002SE |
| K001603 | Reprobead T4 Enzyme Immunoassay Reagent Kit (Catalog# 105)KLI · Traditional | Repromedix Corp. | 10/05/2000SE |
| K000600 | Syva Emit 2000 Thyroxine Assay, CalibratorsKLI · Traditional | Syva Co., Dade Behring, Inc. | 03/27/2000SE |
| K991432 | Biocheck Total T4 Enzyme Immunoassay Test Kit, Model BC-1007KLI · Traditional | Biocheck, Inc. | 06/02/1999SE |
| K982298 | Opticoat T4 Eia KitKLI · Traditional | Biotecx Laboratories, Inc. | 02/03/1999SE |
More from Biotecx Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896867 | Thyroid Stimulating Hormone-Eia-XtJLW · Traditional | 02/23/1990SE |
| K896866 | Luteinizing Hormone-Eia-XtCEP · Traditional | 02/13/1990SE |
| K896863 | Digoxin-Eia-XtKXT · Traditional | 02/13/1990SE |
| K896925 | T Uptake Enzyme Immunoassay Crimped Tube KitKHQ · Traditional | 01/18/1990SE |
| K896864 | Follicle Stimulating Hormone-Eia-XtCGJ · Traditional | 01/11/1990SE |
| K873832 | Reagents for Use on Contraves DC300, DC500, AL801KRZ · Traditional | 11/23/1987SE |
| K871188 | Lithium Internal Standard 1500 Meq/L #60086JIS · Traditional | 05/28/1987SE |
| K871187 | Lithium Internal Standard 3000 Meq/L #60084JIS · Traditional | 05/28/1987SE |
| K871186 | Cesium Diluent 1.5 Mmol Cs/L #60087JIS · Traditional | 05/28/1987SE |
| K871185 | Lithium Internal Standard 1 Meq/L #60085JIS · Traditional | 05/28/1987SE |
Questions and answers
When was Vitro T4-EIA-XT cleared by the FDA?
Vitro T4-EIA-XT (K896865) received a 510(k) decision of Substantially Equivalent on January 30, 1990, 55 days after the submission was received.
What is the product code of K896865?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.