510(k) K982491
K982491 is an FDA 510(k) premarket notification submitted by Sangui Biotech, Inc. for the device "SANGUI BIOTECH, INC. CALCITONIN ELISA KIT". The FDA issued a decision of Substantially Equivalent on September 3, 1998. The device falls under product code JKR (Radioimmunoassay, Calcitonin), a Class II device regulated under 21 CFR 862.1140. Sangui Biotech, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 1998
- Date Received
- July 17, 1998
- 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