510(k) K111534
K111534 is an FDA 510(k) premarket notification submitted by Diatron U.S., Inc. for the device "ABACUS 3CP". The FDA issued a decision of Substantially Equivalent on August 2, 2012. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Diatron U.S., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2012
- Date Received
- June 2, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Differential Cell
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type