510(k) K820299
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1982
- Date Received
- February 4, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent/Device, Inoculum Calibration
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type