510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854685Substantially Equivalent

Digital-9 Key Leucocyte Counter

Future Impex Corp., Deerpark NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854685 is the FDA 510(k) clearance record for DIGITAL-9 KEY LEUCOCYTE COUNTER, a class I device, cleared for Future Impex Corp. on under FDA product code GKM (Hand-Tally, Differential). FDA records list 14 510(k) clearances for Future Impex Corp., from to . As of , FDA records show no recalls naming K854685.

Clearance record

Decision date
Received
(135 days to decision)
Product code
GKM Hand-Tally, Differential
Regulation
21 CFR 864.6160
Device class
Class I
Review panel
Hematology
Applicant
Future Impex Corp. 2076 Deer Park Ave., Deerpark NY
Third party review
No

Clearances, product code GKM

Trailing 12 months

FDA records hold no clearances under product code GKM in the trailing twelve months.

FDA records show no clearances under product code GKM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GKM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260