510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831558Substantially Equivalent

E-Z Prep

Coulter Electronics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831558 is the FDA 510(k) clearance record for E-Z PREP, a class I device, cleared for Coulter Electronics, Inc. on under FDA product code GKJ (Spinner, Slide, Automated). FDA records list 101 510(k) clearances for Coulter Electronics, Inc., from to . As of , FDA records show no recalls naming K831558.

Clearance record

Decision date
Received
(31 days to decision)
Product code
GKJ Spinner, Slide, Automated
Regulation
21 CFR 864.5850
Device class
Class I
Review panel
Hematology
Applicant
Coulter Electronics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GKJ

Trailing 12 months

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

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