510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962988Substantially Equivalent

Coulter Gen-S System

Coulter Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962988 is the FDA 510(k) clearance record for COULTER GEN-S SYSTEM, a class II device, cleared for Coulter Corp. on under FDA product code GKL (Counter, Cell, Automated (Particle Counter)). FDA records list 51 510(k) clearances for Coulter Corp., from to . As of , FDA records show 4 recalls naming K962988.

Clearance record

Decision date
Received
(90 days to decision)
Product code
GKL Counter, Cell, Automated (Particle Counter)
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Coulter Corp. 11800 SW 147th Ave., Miami FL
510(k) summary
Summary
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