Thyroxine (Fpia) Kit
FDA 510(k) K921904 · Tudor Laboratories, Inc.
510(k) numberK921904
Submission
- Device name
- Thyroxine (Fpia) Kit
- Applicant
- Tudor Laboratories, Inc.
Dallas, TX, US - Received
- April 21, 1992
- Decision date
- June 24, 1992
- 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
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| 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 |
|---|---|---|
| K921903 | Thyroxine Calibrator KitJIS · Traditional | 05/26/1992SE |
| K913240 | Digitoxin (Fpia) KitLFM · Traditional | 09/06/1991SE |
| K895572 | N-Acetylprocainamide (Napa) Calibrator KitDLJ · Traditional | 10/30/1989SE |
| K895571 | N-Acetylprocainamide (Napa) (Fpia) KitLAN · Traditional | 10/25/1989SE |
| K895567 | Primidone (Fpia) KitLFT · Traditional | 10/20/1989SE |
| K895569 | Valproic Acid (Fpia) KitLEG · Traditional | 10/03/1989SE |
| K895570 | Valproic Acid (Fpia) Calibrator KitDLJ · Traditional | 09/28/1989SE |
| K895568 | Primidone (Fpia) Calibrator KitDLJ · Traditional | 09/28/1989SE |
Questions and answers
When was Thyroxine (Fpia) Kit cleared by the FDA?
Thyroxine (Fpia) Kit (K921904) received a 510(k) decision of Substantially Equivalent on June 24, 1992, 64 days after the submission was received.
What is the product code of K921904?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.