510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831872Substantially Equivalent

Calibrator 282

Bionostics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831872 is the FDA 510(k) clearance record for CALIBRATOR 282, a class II device, cleared for Bionostics, Inc. on under FDA product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement). FDA records list 49 510(k) clearances for Bionostics, Inc., from to . As of , FDA records show no recalls naming K831872.

Clearance record

Decision date
Received
(35 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
Bionostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
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