510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K865014Substantially Equivalent

Liquichek Immunology Control (Human) Levels I & II

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

K865014 is the FDA 510(k) clearance record for LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II, a class I device, cleared for Bio-Rad on under FDA product code DGR (Whole Human Serum, Antigen, Antiserum, Control). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K865014.

Clearance record

Decision date
Received
(17 days to decision)
Product code
DGR Whole Human Serum, Antigen, Antiserum, Control
Regulation
21 CFR 866.5700
Device class
Class I
Review panel
Immunology
Applicant
Bio-Rad 2400 Wright Ave., Richmond CA
Third party review
No

Clearances, product code DGR

Trailing 12 months

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

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