510(k) K860899
K860899 is an FDA 510(k) premarket notification submitted by Ulster Scientific, Inc. for the device "DISPETTE II". The FDA issued a decision of Substantially Equivalent on Apr 14, 1986. The device falls under product code JPH (Test, Erythrocyte Sedimentation Rate), a Class I device regulated under 21 CFR 864.6700. Ulster Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 14, 1986
- Date Received
- Mar 10, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Erythrocyte Sedimentation Rate
- Device Class
- Class I
- Regulation Number
- 864.6700
- Review Panel
- HE
- Submission Type