510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910745Substantially Equivalent

Hemoglobin Reagent

Toa Medical Electronics USA, Inc., Los Alamitos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910745 is the FDA 510(k) clearance record for HEMOGLOBIN REAGENT, a class II device, cleared for Toa Medical Electronics USA, Inc. on under FDA product code GKR (System, Hemoglobin, Automated). FDA records list 33 510(k) clearances for Toa Medical Electronics USA, Inc., from to . As of , FDA records show no recalls naming K910745.

Clearance record

Decision date
Received
(140 days to decision)
Product code
GKR System, Hemoglobin, Automated
Regulation
21 CFR 864.5620
Device class
Class II
Review panel
Hematology
Applicant
Toa Medical Electronics USA, Inc. 4410 Cerritos Ave., Los Alamitos CA
Third party review
No

Clearances, product code GKR

Trailing 12 months

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

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