510(k) K113521
K113521 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "CALCIUM GEN. 2". The FDA issued a decision of Substantially Equivalent on May 8, 2012. The device falls under product code CHW (Titrimetric With Edta And Indicator, Calcium), a Class II device regulated under 21 CFR 862.1145. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2012
- Date Received
- November 29, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Titrimetric With Edta And Indicator, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type