510(k) K052794
K052794 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "ETI-MAX 3000". The FDA issued a decision of Substantially Equivalent on March 31, 2006. The device falls under product code JJF (Analyzer, Chemistry, Micro, For Clinical Use), a Class I device regulated under 21 CFR 862.2170. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2006
- Date Received
- October 3, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry, Micro, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2170
- Review Panel
- CH
- Submission Type