510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K935343Substantially Equivalent

Centrifiq Blood Control

Hematronix, Inc., Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935343 is the FDA 510(k) clearance record for CENTRIFIQ BLOOD CONTROL, a class II device, cleared for Hematronix, Inc. on under FDA product code JPK (Mixture, Hematology Quality Control). FDA records list 9 510(k) clearances for Hematronix, Inc., from to . As of , FDA records show no recalls naming K935343.

Clearance record

Decision date
Received
(128 days to decision)
Product code
JPK Mixture, Hematology Quality Control
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Hematronix, Inc. 1505 Capital Ave., Plano TX
510(k) summary
Statement
Third party review
No

Clearances, product code JPK

Trailing 12 months

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

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