510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923530Substantially Equivalent

Coulter Multi-Q-Prep

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

K923530 is the FDA 510(k) clearance record for COULTER MULTI-Q-PREP, a class I device, cleared for Coulter Electronics, Inc. on under FDA product code GKH (Apparatus, Automated Blood Cell Diluting). FDA records list 101 510(k) clearances for Coulter Electronics, Inc., from to . As of , FDA records show no recalls naming K923530.

Clearance record

Decision date
Received
(90 days to decision)
Product code
GKH Apparatus, Automated Blood Cell Diluting
Regulation
21 CFR 864.5240
Device class
Class I
Review panel
Hematology
Applicant
Coulter Electronics, Inc. 745 W. 83rd St., Hialeah FL
510(k) summary
Statement
Third party review
No

Clearances, product code GKH

Trailing 12 months

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

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