510(k) K003301
K003301 is an FDA 510(k) premarket notification submitted by CellaVision AB for the device "DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER". The FDA issued a decision of Substantially Equivalent on March 15, 2001. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. CellaVision AB has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2001
- Date Received
- October 20, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Automated Cell-Locating
- Device Class
- Class II
- Regulation Number
- 864.5260
- Review Panel
- HE
- Submission Type