510(k) K854962
K854962 is an FDA 510(k) premarket notification submitted by Ulster Scientific, Inc. for the device "MICRO-MAT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 23, 1985. The device falls under product code GKJ (Spinner, Slide, Automated), a Class I device regulated under 21 CFR 864.5850. Ulster Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 1985
- Date Received
- December 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinner, Slide, Automated
- Device Class
- Class I
- Regulation Number
- 864.5850
- Review Panel
- HE
- Submission Type