Ubi Magiwel Thyroxine (T4) Quantitative
FDA 510(k) K962211 · United Biotech, Inc.
510(k) numberK962211
Submission
- Device name
- Ubi Magiwel Thyroxine (T4) Quantitative
- Applicant
- United Biotech, Inc.
Mountain View, CA, US - Received
- June 10, 1996
- Decision date
- July 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K981573 | Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia QuantitatveJFH · Traditional | 09/15/1998SE |
| K973154 | Ubi Magiwel Marijuana MetabolitesLDJ · Traditional | 07/22/1998SE |
| K973692 | Ubi Magiwel C-Reactive Protein(Crp) QuantitativeDCK · Traditional | 02/09/1998SE |
| K973156 | Ubi Magiwel Cocaine MetabolitesDJG · Traditional | 10/28/1997SE |
| K973155 | Ubi Magiwel Opiate MetabolitesDJG · Traditional | 10/28/1997SE |
| K973153 | Ubi Magiwel Amphetamine MetabolitesDJG · Traditional | 10/28/1997SE |
| K961236 | Ubi Magiwel TRIIODOTHYRONINE(T3) QuantitativeCDP · Traditional | 05/30/1996SE |
| K951993 | Ubi Magiwel Ferritin QuantitativeDBF · Traditional | 07/05/1995SE |
| K924689 | Ubi Magiwel(Tm) Helicobacter Pylori IggLYR · Traditional | 08/10/1993SE |
| K905473 | Ubi Magiwel Cortisol QuantitativeCGR · Traditional | 01/31/1991SE |
Questions and answers
When was Ubi Magiwel Thyroxine (T4) Quantitative cleared by the FDA?
Ubi Magiwel Thyroxine (T4) Quantitative (K962211) received a 510(k) decision of Substantially Equivalent on July 8, 1996, 28 days after the submission was received.
What is the product code of K962211?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.