AIA-1200DX - Automated Enzyme Immunoassay System
FDA 510(k) K923021 · Tosoh Corp.
510(k) numberK923021
Submission
- Device name
- AIA-1200DX - Automated Enzyme Immunoassay System
- Applicant
- Tosoh Corp.
Washington, D.C., DC, US - Received
- June 23, 1992
- Decision date
- July 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 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 |
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Questions and answers
When was AIA-1200DX - Automated Enzyme Immunoassay System cleared by the FDA?
AIA-1200DX - Automated Enzyme Immunoassay System (K923021) received a 510(k) decision of Substantially Equivalent on July 21, 1992, 28 days after the submission was received.
What is the product code of K923021?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.