510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K891475Substantially Equivalent

Lyphochek(r) Immunoassay Contr Serum (Human) 1,2,3

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

K891475 is the FDA 510(k) clearance record for LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3, a class I device, cleared for Bio-Rad on under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K891475.

Clearance record

Decision date
Received
(138 days to decision)
Product code
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bio-Rad 4000 Alfred Nobel Dr., Hercules CA
Third party review
No

Clearances, product code JJX

Trailing 12 months

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

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