510(k) K854685
K854685 is an FDA 510(k) premarket notification submitted by Future Impex Corp. for the device "DIGITAL-9 KEY LEUCOCYTE COUNTER". The FDA issued a decision of Substantially Equivalent on April 4, 1986. The device falls under product code GKM (Hand-Tally, Differential), a Class I device regulated under 21 CFR 864.6160. Future Impex Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1986
- Date Received
- November 20, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hand-Tally, Differential
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type