T4 Microwell Eia (Enzyme IMMUNOASSAY0
FDA 510(k) K950588 · Biomerica, Inc.
510(k) numberK950588
Submission
- Device name
- T4 Microwell Eia (Enzyme IMMUNOASSAY0
- Applicant
- Biomerica, Inc.
Newport Beach, CA, US - Received
- February 9, 1995
- Decision date
- June 29, 1995
- 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 |
|---|---|---|
| K232892 | Hp Detect Stool Antigen ELISALYR · Traditional | 12/15/2023SE |
| K003856 | Ez-Hcg Urine(Pregnancy Test)JHI · Traditional | 02/21/2001SE |
| K982954 | Free T4 Microwell Eia, Model #7019CEC · Traditional | 09/24/1998SE |
| K962216 | TSH (Microwell) ElisaJLW · Traditional | 09/19/1996SE |
| K960412 | T-3 Microwell Eia Model 7013CDP · Traditional | 03/19/1996SE |
| K954256 | Anti-TpoJNL · Traditional | 11/27/1995SE |
| K936010 | Thyroglobulin Autoantibody Enzyme ImmunoassayDDC · Traditional | 07/18/1994SE |
| K915185 | Gap Igg H.Pylori ModifiedLYR · Traditional | 03/04/1992SE |
| K900343 | Gap-IggLYR · Traditional | 08/22/1991SE |
Questions and answers
When was T4 Microwell Eia (Enzyme IMMUNOASSAY0 cleared by the FDA?
T4 Microwell Eia (Enzyme IMMUNOASSAY0 (K950588) received a 510(k) decision of Substantially Equivalent on June 29, 1995, 140 days after the submission was received.
What is the product code of K950588?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.