510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K882600Substantially Equivalent

Hemocue Hemoglobin Calibrator

React and Co., Manhattan Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882600 is the FDA 510(k) clearance record for HEMOCUE HEMOGLOBIN CALIBRATOR, a class II device, cleared for React and Co. on under FDA product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement). FDA records list one 510(k) clearance for React and Co. As of , FDA records show no recalls naming K882600.

Clearance record

Decision date
Received
(24 days to decision)
Product code
KRZ Calibrator For Hemoglobin And Hematocrit Measurement
Regulation
21 CFR 864.8165
Device class
Class II
Review panel
Hematology
Applicant
React and Co. 1142 Manhattan Ave., Manhattan Beach CA
Third party review
No

Clearances, product code KRZ

Trailing 12 months

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

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