Immulite(Tm) Total T4
FDA 510(k) K910261 · Cirrus Diagnostics, Inc.
510(k) numberK910261
Submission
- Device name
- Immulite(Tm) Total T4
- Applicant
- Cirrus Diagnostics, Inc.
Chester, NJ, US - Received
- January 22, 1991
- Decision date
- April 16, 1991
- 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 |
|---|---|---|
| K921704 | Immulite(R) FSHCGJ · Traditional | 06/09/1992SE |
| K920411 | Immulite HLHCEP · Traditional | 03/11/1992SE |
| K914833 | Immulite DigoxinDPO · Traditional | 11/22/1991SE |
| K911796 | Immulite(Tm) HCGDHA · Traditional | 06/20/1991SE |
| K910677 | Immulite(Tm) T-UptakeCEE · Traditional | 04/29/1991SE |
| K905648 | CRP Lipid Reagent Test PackCHH · Traditional | 03/06/1991SE |
| K905214 | Immulite (TM) Total T3CDP · Traditional | 02/01/1991SE |
| K905769 | Immulite Hs-TshJLW · Traditional | 01/31/1991SE |
| K905215 | Immulite (TM) Automated Immunoassay AnalyzerJJQ · Traditional | 01/11/1991SE |
Questions and answers
When was Immulite(Tm) Total T4 cleared by the FDA?
Immulite(Tm) Total T4 (K910261) received a 510(k) decision of Substantially Equivalent on April 16, 1991, 84 days after the submission was received.
What is the product code of K910261?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.