510(k) K811674
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 1981
- Date Received
- June 15, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrators, Drug Mixture
- Device Class
- Class II
- Regulation Number
- 862.3200
- Review Panel
- TX
- Submission Type