510(k) K010696
K010696 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "BECKMAN COULTER DNASE B CALIBRATOR". The FDA issued a decision of Substantially Equivalent on May 10, 2001. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2001
- Date Received
- March 8, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Primary
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type