510(k) K062855
K062855 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "CALCIUM". The FDA issued a decision of Substantially Equivalent on November 22, 2006. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2006
- Date Received
- September 25, 2006
- 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