510(k) K955719
K955719 is an FDA 510(k) premarket notification submitted by Medicus Technologies, Inc. for the device "SICKLE-2000". The FDA issued a decision of Substantially Equivalent on August 14, 1996. The device falls under product code GIQ (Hemoglobin S), a Class II device regulated under 21 CFR 864.7415.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 1996
- Date Received
- December 18, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemoglobin S
- Device Class
- Class II
- Regulation Number
- 864.7415
- Review Panel
- HE
- Submission Type