510(k) K982608
K982608 is an FDA 510(k) premarket notification submitted by Sangui Biotech, Inc. for the device "SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT". The FDA issued a decision of Substantially Equivalent on August 19, 1998. The device falls under product code CKG (Radioimmunoassay, Acth), a Class II device regulated under 21 CFR 862.1025. Sangui Biotech, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1998
- Date Received
- July 27, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Acth
- Device Class
- Class II
- Regulation Number
- 862.1025
- Review Panel
- CH
- Submission Type