510(k) K002638
K002638 is an FDA 510(k) premarket notification submitted by Future Diagnostics B.V. for the device "FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT". The FDA issued a decision of Substantially Equivalent on January 17, 2001. The device falls under product code CKG (Radioimmunoassay, Acth), a Class II device regulated under 21 CFR 862.1025. Future Diagnostics B.V. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2001
- Date Received
- August 24, 2000
- 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