510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821851Substantially Equivalent

Control Diagnostics Platelet Control

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

K821851 is the FDA 510(k) clearance record for CONTROL DIAGNOSTICS PLATELET CONTROL, a class II device, cleared for Immunogenetics on under FDA product code KRY (Calibrator For Platelet Counting). FDA records list one 510(k) clearance for Immunogenetics. As of , FDA records show no recalls naming K821851.

Clearance record

Decision date
Received
(71 days to decision)
Product code
KRY Calibrator For Platelet Counting
Regulation
21 CFR 864.8175
Device class
Class II
Review panel
Hematology
Applicant
Immunogenetics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KRY

Trailing 12 months

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

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