Nichols Advantage Chemiluminescence Free T4- Estimate Kit
FDA 510(k) K962408 · Nichols Institute Diagnostics
510(k) numberK962408
Submission
- Device name
- Nichols Advantage Chemiluminescence Free T4- Estimate Kit
- Applicant
- Nichols Institute Diagnostics
San Juan Capistrano, CA, US - Received
- June 21, 1996
- Decision date
- March 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1695
- Specialty
- Clinical Chemistry
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| K140859 | Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid…CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/26/2014SE |
| K140842 | Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/26/2014SE |
| K131244 | Elecsys FT4 II Assay, Elecsys FT4 II CalsetCEC · Traditional | Roche Diagnostics | 01/27/2014SE |
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| K033302 | Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040CEW · Special | 01/26/2004SE |
| K032188 | Nichols Advantage Aldosterone AssayCJM · Traditional | 07/31/2003SE |
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| K022472 | Parathyroid Hormone Test System/Nichols Advantage Quick-Intraoperative Bio-Intact PTH…CEW · Traditional | 10/09/2002SE |
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Questions and answers
When was Nichols Advantage Chemiluminescence Free T4- Estimate Kit cleared by the FDA?
Nichols Advantage Chemiluminescence Free T4- Estimate Kit (K962408) received a 510(k) decision of Substantially Equivalent on March 18, 1997, 270 days after the submission was received.
What is the product code of K962408?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.