510(k) K021150
K021150 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "COULTER CELLPREP". The FDA issued a decision of Substantially Equivalent on June 11, 2002. The device falls under product code GKH (Apparatus, Automated Blood Cell Diluting), a Class I device regulated under 21 CFR 864.5240. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2002
- Date Received
- April 10, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Automated Blood Cell Diluting
- Device Class
- Class I
- Regulation Number
- 864.5240
- Review Panel
- HE
- Submission Type