510(k) K991839
K991839 is an FDA 510(k) premarket notification submitted by Abx Diagnostics for the device "ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER". The FDA issued a decision of Substantially Equivalent on August 11, 1999. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Abx Diagnostics has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1999
- Date Received
- May 28, 1999
- 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