510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K011579Substantially Equivalent

Lyphochek Tumor Marker Control, Levels 1 and 2, 2Ml, Model 580

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

K011579 is the FDA 510(k) clearance record for LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580, a class I device, cleared for Bio-Rad on under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K011579.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JJY Multi-Analyte Controls, All Kinds (Assayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bio-Rad 9500 Jeronimo Rd., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code JJY

Trailing 12 months

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

FDA records show no clearances under product code JJY in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260