510(k) K141426
K141426 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECSYS FOLATE III". The FDA issued a decision of Substantially Equivalent on October 17, 2014. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2014
- Date Received
- May 30, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Folic, Radioimmunoassay
- Device Class
- Class II
- Regulation Number
- 862.1295
- Review Panel
- CH
- Submission Type