510(k) K080812
K080812 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "HEMOCCULT ICT". The FDA issued a decision of Substantially Equivalent on June 25, 2008. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2008
- Date Received
- March 24, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Occult Blood
- Device Class
- Class II
- Regulation Number
- 864.6550
- Review Panel
- HE
- Submission Type