510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964452Substantially Equivalent

Hematachek

Richmond Diagnostics, Inc., New Brunswick NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964452 is the FDA 510(k) clearance record for HEMATACHEK, a class II device, cleared for Richmond Diagnostics, Inc. on under FDA product code GLK (Control, Hematocrit). FDA records list one 510(k) clearance for Richmond Diagnostics, Inc. As of , FDA records show no recalls naming K964452.

Clearance record

Decision date
Received
(106 days to decision)
Product code
GLK Control, Hematocrit
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Richmond Diagnostics, Inc. 100 Jersey Ave., Suite 202a,, New Brunswick NJ
510(k) summary
Statement
Third party review
No

Clearances, product code GLK

Trailing 12 months

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

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