Aia-Pack FT4
FDA 510(k) K913493 · Tosoh Corp.
510(k) numberK913493
Submission
- Device name
- Aia-Pack FT4
- Applicant
- Tosoh Corp.
Washington, D.C., DC, US - Received
- August 6, 1991
- Decision date
- September 10, 1991
- 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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| 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 |
More from Roche Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K023240 | ST Aia-Pack Ca 19-9NIG · Traditional | 12/23/2002SE |
| K023239 | Aia-Pack Ca 19-9NIG · Traditional | 12/23/2002SE |
| K923021 | AIA-1200DX - Automated Enzyme Immunoassay SystemKHO · Traditional | 07/21/1992SE |
| K913663 | Aia-Pack T-UKHQ · Traditional | 09/30/1991SE |
| K913298 | Aia-Pack Ck-MbJHX · Traditional | 09/27/1991SE |
| K903628 | Aia-Pack IriCFP · Traditional | 09/07/1990SE |
| K901965 | MPR-4A - Micro-Plate ReaderJJQ · Traditional | 05/10/1990SE |
| K901674 | AIA-600 Automated Enzyme Immunoassay SystemKHO · Traditional | 05/02/1990SE |
| K897001 | Tosoh Aia-Pack T3CDP · Traditional | 03/09/1990SE |
| K896982 | Aia-Pack T4KLI · Traditional | 03/09/1990SE |
Questions and answers
When was Aia-Pack FT4 cleared by the FDA?
Aia-Pack FT4 (K913493) received a 510(k) decision of Substantially Equivalent on September 10, 1991, 35 days after the submission was received.
What is the product code of K913493?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.