510(k) K951708
K951708 is an FDA 510(k) premarket notification submitted by Cis-Us, Inc. for the device "ELSA-HCT". The FDA issued a decision of Substantially Equivalent on September 5, 1995. The device falls under product code JKR (Radioimmunoassay, Calcitonin), a Class II device regulated under 21 CFR 862.1140. Cis-Us, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 1995
- Date Received
- April 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Calcitonin
- Device Class
- Class II
- Regulation Number
- 862.1140
- Review Panel
- CH
- Submission Type