Mago Automated Eia Processor
FDA 510(k) K973177 · Diamedix Corp.
510(k) numberK973177
Submission
- Device name
- Mago Automated Eia Processor
- Applicant
- Diamedix Corp.
Miami, FL, US - Received
- August 25, 1997
- Decision date
- October 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2170
- Specialty
- Clinical Chemistry
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| 510(k) | Device | Decision |
|---|---|---|
| K093101 | Mago 4SLFX · Traditional | 01/21/2011SE |
| K021394 | Diamedix Is-Rheumatoid Factor Test SystemDHR · Traditional | 07/09/2002SE |
| K013956 | Diamedix IS-ANTI-B2 Glycoprotein I ScreenMSV · Traditional | 01/08/2002SE |
| K013628 | Diamedix IS-ANTI-B2 Glycoprotein I Igg/Igm Test SystemMSV · Traditional | 12/21/2001SE |
| K012450 | Diamedix Is-Anti-Cardiolipin Iga Test SystemMID · Traditional | 10/26/2001SE |
| K012449 | Diamedix Is-Anti-Cardiolipin Igg/Igm Test SystemMID · Traditional | 10/26/2001SE |
| K012797 | Diamedix Is-Anti-Gliadin Iga Test SystemMST · Traditional | 09/28/2001SE |
| K012795 | Diamedix Is-Anti-Gliadin Igg Test SystemMST · Traditional | 09/28/2001SE |
| K012053 | Diamedix Is-Anti-Cardiolipin Screen Test SystemMID · Traditional | 08/20/2001SE |
| K002262 | Diamedix Is-Hsv 1&2 Igm Test SystemLGC · Traditional | 11/28/2000SE |
Questions and answers
When was Mago Automated Eia Processor cleared by the FDA?
Mago Automated Eia Processor (K973177) received a 510(k) decision of Substantially Equivalent on October 9, 1997, 45 days after the submission was received.
What is the product code of K973177?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.