510(k) K010670
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2001
- Date Received
- March 6, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mercuric Thiocyanate, Colorimetry, Chloride
- Device Class
- Class II
- Regulation Number
- 862.1170
- Review Panel
- CH
- Submission Type