Nat. Screening Institute Micro-Plate Free T4 Assay
FDA 510(k) K925649 · Solarcare Technologies Corp,Inc.
510(k) numberK925649
Submission
- Device name
- Nat. Screening Institute Micro-Plate Free T4 Assay
- Applicant
- Solarcare Technologies Corp,Inc.
Bethlehem, PA, US - Received
- November 9, 1992
- Decision date
- March 1, 1993
- 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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| K181233 | Elecsys FT4 IIICEC · Traditional | Roche Diagnostics | 09/18/2018SE |
| K173122 | Abbott Architect Free T4CEC · Special | Abbott Laboratories | 10/27/2017SE |
| K152422 | FREND Free T4 Test SystemCEC · Traditional | Nanoentek USA, Inc. | 02/17/2016SE |
| K132058 | Vidas FT4CEC · Traditional | Biomerieux S.A. | 06/08/2015SE |
| 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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Questions and answers
When was Nat. Screening Institute Micro-Plate Free T4 Assay cleared by the FDA?
Nat. Screening Institute Micro-Plate Free T4 Assay (K925649) received a 510(k) decision of Substantially Equivalent on March 1, 1993, 112 days after the submission was received.
What is the product code of K925649?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.