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
K962864Substantially Equivalent

Thb Cal Standard for Il Co-Oximeters/oximeters

Alko Diagnostic Corp., Holliston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962864 is the FDA 510(k) clearance record for THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS, a class II device, cleared for Alko Diagnostic Corp. on under FDA product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement). FDA records list 31 510(k) clearances for Alko Diagnostic Corp., from to . As of , FDA records show no recalls naming K962864.

Clearance record

Decision date
Received
(148 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
Alko Diagnostic Corp. 333 Fiske St., Holliston MA
510(k) summary
Summary
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