T4 Clasp-Bead Eia Kit
FDA 510(k) K892853 · Biotecx Laboratories, Inc.
510(k) numberK892853
Submission
- Device name
- T4 Clasp-Bead Eia Kit
- Applicant
- Biotecx Laboratories, Inc.
Friendswood, TX, US - Received
- April 18, 1989
- Decision date
- May 22, 1989
- 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 |
|---|---|---|
| K982298 | Opticoat T4 Eia KitKLI · Traditional | 02/03/1999SE |
| K981824 | Opticoat T3 Eia KitCDP · Traditional | 12/22/1998SE |
| K895407 | Cortisol Clasp-Bead Eia KitCGR · Traditional | 10/19/1989SE |
| K893620 | T3 Clasp-Bead Eia KitCDP · Traditional | 08/11/1989SE |
| K883765 | TBG 125I Ria Kit, Radioimmuno. of Serum ThyroxineKHQ · Traditional | 10/31/1988SE |
| K871211 | Progesterone Clasp Radioimmunoassay KitJLS · Traditional | 04/13/1987SE |
| K863188 | HPL Ria KitJMX · Traditional | 09/25/1986SE |
| K854876 | Aldosterone Direct Ria KitKQN · Traditional | 03/17/1986SE |
| K851540 | Estradiol Direct Ria KitCHP · Traditional | 06/06/1985SE |
| K844767 | Radioimmunoassay of Human Serum Plasma or Urine toCGI · Traditional | 02/01/1985SE |
Questions and answers
When was T4 Clasp-Bead Eia Kit cleared by the FDA?
T4 Clasp-Bead Eia Kit (K892853) received a 510(k) decision of Substantially Equivalent on May 22, 1989, 34 days after the submission was received.
What is the product code of K892853?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.