D-Chem Total T4 Test Kit for Thyroxine Quantita.
FDA 510(k) K896329 · Photec Diagnostics, Inc.
510(k) numberK896329
Submission
- Device name
- D-Chem Total T4 Test Kit for Thyroxine Quantita.
- Applicant
- Photec Diagnostics, Inc.
Mahwah, NJ, US - Received
- November 2, 1989
- Decision date
- December 12, 1989
- 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
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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 |
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| K892224 | D-Chem(Tm) T-Uptake Test Kit for T-Uptake DeterminKHQ · Traditional | 06/16/1989SE |
| K890267 | Quikread Chem. Analyzer & Choles. for Serum/PlasmaCHH · Traditional | 04/26/1989SE |
| K890027 | Quikread Chem. Analyzer & Choles. for Whole BloodCHH · Traditional | 04/26/1989SE |
| K882307 | D-ChemJJE · Traditional | 08/02/1988SE |
| K880291 | Theophylline Test Kit Ref. #A874799LCA · Traditional | 03/24/1988SE |
| K854875 | Apo-Screen Calibrator & Control Set for HDL Apo A1DER · Traditional | 01/24/1986SE |
| K853048 | Apo-Screen Test Set for Hdl-Apolipoptein A-1DER · Traditional | 08/28/1985SE |
| K853174 | Apo-Chrome Immunoassay Test Set for ApolipoproteinMSJ · Traditional | 08/22/1985SE |
Questions and answers
When was D-Chem Total T4 Test Kit for Thyroxine Quantita. cleared by the FDA?
D-Chem Total T4 Test Kit for Thyroxine Quantita. (K896329) received a 510(k) decision of Substantially Equivalent on December 12, 1989, 40 days after the submission was received.
What is the product code of K896329?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.