Vidas Thyroxine (T4) Assay (T4)
FDA 510(k) K926393 · Biomerieux Vitek, Inc.
510(k) numberK926393
Submission
- Device name
- Vidas Thyroxine (T4) Assay (T4)
- Applicant
- Biomerieux Vitek, Inc.
Rockland, MA, US - Received
- December 21, 1992
- Decision date
- May 13, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K973819 | Vidas D-Dimer (DD) AssayDAP · Traditional | 03/10/1998SE |
| K972895 | Vidas Rotavirus (RTV) AssayLIQ · Traditional | 10/03/1997SE |
| K965092 | Vidas Rotavirus AssayLIQ · Traditional | 05/05/1997SE |
| K964887 | Vidas C. Difficile Toxin a II AssayLLH · Traditional | 04/08/1997SE |
| K955627 | Vidas Chlamydia Blocking AssayLJC · Traditional | 10/07/1996SE |
| K962609 | Gram Negative Identification Plus CardLRH · Traditional | 08/30/1996SE |
| K962549 | Vidas Creatine Kinase MB Assay 30-421JHX · Traditional | 08/30/1996SE |
| K952095 | Vitek Gram Positive Identification Card (Gpi)LQL · Traditional | 03/12/1996SE |
| K955647 | Vidas Estradiol II (E2II) AssayCHP · Traditional | 02/06/1996SE |
| K943812 | Vidas Lyme Screen IILSR · Traditional | 06/13/1995SE |
Questions and answers
When was Vidas Thyroxine (T4) Assay (T4) cleared by the FDA?
Vidas Thyroxine (T4) Assay (T4) (K926393) received a 510(k) decision of Substantially Equivalent on May 13, 1993, 143 days after the submission was received.
What is the product code of K926393?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.