T4 Serozyme Enzymeimmunoassay Kit/Mag. Solid Phase
FDA 510(k) K874866 · Serono Diagnostics, Inc.
510(k) numberK874866
Submission
- Device name
- T4 Serozyme Enzymeimmunoassay Kit/Mag. Solid Phase
- Applicant
- Serono Diagnostics, Inc.
Norwell, MA, US - Received
- November 27, 1987
- Decision date
- February 11, 1988
- 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 |
|---|---|---|
| K953598 | Series 9100 Plus Automated Differential Hematology AnalyzersGKZ · Traditional | 03/11/1996SE |
| K942051 | SR1 Dhea-S Enzyme ImmunoassayJKC · Traditional | 07/13/1994SE |
| K883085 | T3 Uptake Serozyme Enzyme Immuno Kt/Mag Solid PhasKHQ · Traditional | 09/09/1988SE |
| K882340 | LH Serozyme Immunoenzymetric Assay Kit,Mag Sol PhaCEP · Traditional | 08/08/1988SE |
| K880388 | T3 Serozyme Enzymeimmunoassay Kit, Mag Solid PhaseCDP · Traditional | 03/03/1988SE |
| K873431 | Progesterone Maia Radioimmuno Assay Kit Mag SLD PHJLS · Traditional | 10/20/1987SE |
| K873186 | LH Maiaclone Immunoradio. Assay Kit, Mag Solid PhaCEP · Traditional | 09/29/1987SE |
| K873400 | Prolactin Maiaclone Immunoradio. Kit, Mag Sol PhaCFT · Traditional | 09/25/1987SE |
| K872862 | PRL Serozyme Immunoenz. Assay Kit, Mag. Solid PhasCFT · Traditional | 09/18/1987SE |
| K873033 | HCG Serozyme Immunoenzym Assay Kit/Mag Solid PhaseJHI · Traditional | 09/14/1987SE |
Questions and answers
When was T4 Serozyme Enzymeimmunoassay Kit/Mag. Solid Phase cleared by the FDA?
T4 Serozyme Enzymeimmunoassay Kit/Mag. Solid Phase (K874866) received a 510(k) decision of Substantially Equivalent on February 11, 1988, 76 days after the submission was received.
What is the product code of K874866?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.