510(k) K961278
K961278 is an FDA 510(k) premarket notification submitted by Coulter Corp. for the device "COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS". The FDA issued a decision of Substantially Equivalent on July 22, 1996. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Coulter Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 1996
- Date Received
- April 3, 1996
- 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