Eti-Max 3000
FDA 510(k) K052794 · DiaSorin, Inc.
510(k) numberK052794
Submission
- Device name
- Eti-Max 3000
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- October 3, 2005
- Decision date
- March 31, 2006
- 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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Questions and answers
When was Eti-Max 3000 cleared by the FDA?
Eti-Max 3000 (K052794) received a 510(k) decision of Substantially Equivalent on March 31, 2006, 179 days after the submission was received.
What is the product code of K052794?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.