510(k) K964452
K964452 is an FDA 510(k) premarket notification submitted by Richmond Diagnostics, Inc. for the device "HEMATACHEK". The FDA issued a decision of Substantially Equivalent on February 20, 1997. The device falls under product code GLK (Control, Hematocrit), a Class II device regulated under 21 CFR 864.8625.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 1997
- Date Received
- November 6, 1996
- 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