510(k) K974306
K974306 is an FDA 510(k) premarket notification submitted by Sangui Biotech, Inc. for the device "SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA". The FDA issued a decision of Substantially Equivalent on December 23, 1997. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Sangui Biotech, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 1997
- Date Received
- November 17, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Parathyroid Hormone
- Device Class
- Class II
- Regulation Number
- 862.1545
- Review Panel
- CH
- Submission Type