SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase)
FDA 510(k) K911217 · Serono-Baker Diagnostics, Inc.
510(k) numberK911217
Submission
- Device name
- SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase)
- Applicant
- Serono-Baker Diagnostics, Inc.
Allentown, PA, US - Received
- March 19, 1991
- Decision date
- August 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K924257 | Testosterone Serozyme(Tm) Enzyme ImmunoassayCDZ · Traditional | 11/30/1992SE |
| K915164 | Sri Testosterone Enzyme ImmunoassayCDZ · Traditional | 03/02/1992SE |
| K914886 | Sri(Tm) Cortisol Enzyme Immunoassay(Mag Sol Phase)CGR · Traditional | 03/02/1992SE |
| K915602 | Sri Digoxin Enzyme ImmunoassayKXT · Traditional | 01/17/1992SE |
| K912937 | SR1 Free T4 Enzyme ImmunoassayCEC · Traditional | 11/19/1991SE |
| K914462 | Sri Progesterone Enzyme Immunoassay(Mag Sold Phas)JLS · Traditional | 10/23/1991SE |
| K911912 | SR1 T3 Uptake Enzyme Immunoassay(Mag Solid-Phase)KHQ · Traditional | 09/18/1991SE |
| K912318 | Estradiol Serozyme Enzyme Immuno (Mag Solid-Phase)CHP · Traditional | 07/25/1991SE |
| K911396 | SR1 Estradiol Enzyme ImmunoassayCHP · Traditional | 05/28/1991SE |
| K910837 | Sri TSH Immunenzymetric AssayJLW · Traditional | 05/24/1991SE |
Questions and answers
When was SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase) cleared by the FDA?
SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase) (K911217) received a 510(k) decision of Substantially Equivalent on August 16, 1991, 150 days after the submission was received.
What is the product code of K911217?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.