510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K862374Substantially Equivalent

Cellect 8E Automated Blood Cell Counters

Instrumentation Laboratory Co., Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862374 is the FDA 510(k) clearance record for CELLECT 8E AUTOMATED BLOOD CELL COUNTERS, a class II device, cleared for Instrumentation Laboratory CO on under FDA product code GKL (Counter, Cell, Automated (Particle Counter)). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K862374.

Clearance record

Decision date
Received
(72 days to decision)
Product code
GKL Counter, Cell, Automated (Particle Counter)
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Instrumentation Laboratory CO 113 Hartwell Ave., Lexington MA
Third party review
No

Clearances, product code GKL

Trailing 12 months

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

FDA records show no clearances under product code GKL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GKL, 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