510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K862186Substantially Equivalent

Lyphochek Glycated Hemoglobin/whole Blood/lev.i&ii

Bio-Rad, Richmond CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862186 is the FDA 510(k) clearance record for LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II, a class II device, cleared for Bio-Rad on under FDA product code JPK (Mixture, Hematology Quality Control). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K862186.

Clearance record

Decision date
Received
(22 days to decision)
Product code
JPK Mixture, Hematology Quality Control
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Bio-Rad 2400 Wright Ave., Richmond CA
Third party review
No

Clearances, product code JPK

Trailing 12 months

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

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