510(k) K120626
K120626 is an FDA 510(k) premarket notification submitted by Vital Diagnostics (Manufacturing) Ptyltd for the device "EON CALCIUM REGENT". The FDA issued a decision of Substantially Equivalent on August 22, 2012. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. Vital Diagnostics (Manufacturing) Ptyltd has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2012
- Date Received
- March 1, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Azo Dye, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type