AIA-600 Automated Enzyme Immunoassay System
FDA 510(k) K901674 · Tosoh Corp.
510(k) numberK901674
Submission
- Device name
- AIA-600 Automated Enzyme Immunoassay System
- Applicant
- Tosoh Corp.
Washington, D.C., DC, US - Received
- April 10, 1990
- Decision date
- May 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHO – Fluorometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2560
- Specialty
- Clinical Chemistry
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| K935047 | Auto DelfiaKHO · Traditional | Wallac OY | 05/23/1994SE |
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| K923021 | AIA-1200DX - Automated Enzyme Immunoassay SystemKHO · Traditional | Tosoh Corp. | 07/21/1992SE |
More from Tosoh Corp.
| 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 |
| K913493 | Aia-Pack FT4CEC · Traditional | 09/10/1991SE |
| K903628 | Aia-Pack IriCFP · Traditional | 09/07/1990SE |
| K901965 | MPR-4A - Micro-Plate ReaderJJQ · Traditional | 05/10/1990SE |
| K897001 | Tosoh Aia-Pack T3CDP · Traditional | 03/09/1990SE |
| K896982 | Aia-Pack T4KLI · Traditional | 03/09/1990SE |
Questions and answers
When was AIA-600 Automated Enzyme Immunoassay System cleared by the FDA?
AIA-600 Automated Enzyme Immunoassay System (K901674) received a 510(k) decision of Substantially Equivalent on May 2, 1990, 22 days after the submission was received.
What is the product code of K901674?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.