THYROXIN(T4) Enzyme Immunoassay Test Kit
FDA 510(k) K897144 · Medix Biotech, Inc.
510(k) numberK897144
Submission
- Device name
- THYROXIN(T4) Enzyme Immunoassay Test Kit
- Applicant
- Medix Biotech, Inc.
Foster City, CA, US - Received
- December 27, 1989
- Decision date
- March 15, 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 |
|---|---|---|
| K952873 | Medix Biotech Strep a Antigen Detection Test (Modification)GTZ · Traditional | 09/08/1995SE |
| K952319 | Contrast & Rapid HCG Urine/Serum TSTJHI · Traditional | 06/20/1995SE |
| K932482 | Medix Biotech Bestest Strep a Cat. No. BSF1010GTZ · Traditional | 07/18/1994SE |
| K932758 | Medix Biotech Bestest Hcg-Urine Test KitJHI · Traditional | 09/28/1993SE |
| K925436 | Medix Biotech Total T3 Enzyme Immunoassay Test KitCDP · Traditional | 12/28/1992SE |
| K924259 | Medix Biotech Bestest(Tm) Hcg-Urine, Cat# B1H0100JHI · Traditional | 11/25/1992SE |
| K922047 | Ige Enzyme Immunoassay Test Kit Cat.No. KIF4064DGC · Traditional | 08/05/1992SE |
| K921700 | TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093JLW · Traditional | 06/29/1992SE |
| K920712 | Medix Biotech Throxine Enzyme Immunoassay Test KitKLI · Traditional | 03/27/1992SE |
| K920345 | Prolactin Enzyme Immunoassay Test Kit (Modified)CFT · Traditional | 03/18/1992SE |
Questions and answers
When was THYROXIN(T4) Enzyme Immunoassay Test Kit cleared by the FDA?
THYROXIN(T4) Enzyme Immunoassay Test Kit (K897144) received a 510(k) decision of Substantially Equivalent on March 15, 1990, 78 days after the submission was received.
What is the product code of K897144?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.