510(k) K924926
K924926 is an FDA 510(k) premarket notification submitted by Medical Specialties, Inc. for the device "MSI-HCT". The FDA issued a decision of Substantially Equivalent on January 7, 1993. The device falls under product code GLK (Control, Hematocrit), a Class II device regulated under 21 CFR 864.8625. Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1993
- Date Received
- September 30, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Hematocrit
- Device Class
- Class II
- Regulation Number
- 864.8625
- Review Panel
- HE
- Submission Type