510(k) K884346
K884346 is an FDA 510(k) premarket notification submitted by Coulter Immunology for the device "CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI". The FDA issued a decision of Substantially Equivalent on December 27, 1988. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Coulter Immunology has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 1988
- Date Received
- October 14, 1988
- 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