510(k) K831079
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1983
- Date Received
- April 4, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pipette, Quantitative, Hematology
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type