510(k) K905226
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1990
- Date Received
- November 20, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetric Method, Triglycerides
- Device Class
- Class I
- Regulation Number
- 862.1705
- Review Panel
- CH
- Submission Type