Biocircuits Ios T4/TU Test Cartridges
FDA 510(k) K952751 · Biocircuits Corp.
510(k) numberK952751
Submission
- Device name
- Biocircuits Ios T4/TU Test Cartridges
- Applicant
- Biocircuits Corp.
Sunnyvale, CA, US - Received
- June 15, 1995
- Decision date
- November 20, 1995
- 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 |
|---|---|---|
| K981634 | Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa…LTJ · Traditional | 10/13/1998SE |
| K980819 | Biocircuits Ios Free Thyroxine (FT4) Test Cartridges Biocircuits Ios ControlsCEC · Traditional | 04/03/1998SE |
| K963770 | Biocircuits Ios Quantitative HCG Test Cartridges/Biocircuits Ios Immunoassay ControlsJJY · Traditional | 12/05/1996SE |
| K961566 | Biocircuits Ios TSH Test Cartridges/Thyroid ControlsJLW · Traditional | 11/18/1996SE |
| K961792 | Biocircuits Ios Serum Pregnancy Test Cartridges/Immunoassay ControlsDHA · Traditional | 08/21/1996SE |
| K952719 | Biocircuits Ios (In-Office System)KHO · Traditional | 11/22/1995SE |
| K953837 | Biocircuits Ios T4 Test CartridgeKLI · Traditional | 11/20/1995SE |
Questions and answers
When was Biocircuits Ios T4/TU Test Cartridges cleared by the FDA?
Biocircuits Ios T4/TU Test Cartridges (K952751) received a 510(k) decision of Substantially Equivalent on November 20, 1995, 158 days after the submission was received.
What is the product code of K952751?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.