510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902892Substantially Equivalent

Cell-Dyn Calibrator

Unipath, Ltd., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902892 is the FDA 510(k) clearance record for CELL-DYN CALIBRATOR, a class II device, cleared for Unipath , Ltd. on under FDA product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement). FDA records list 73 510(k) clearances for Unipath , Ltd., from to . As of , FDA records show one recall naming K902892.

Clearance record

Decision date
Received
(70 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
Unipath , Ltd. 850 Maude Ave., Mountain View 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