510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K984323Substantially Equivalent

Architect Lh Mastercheck, Model Number 6C25-05

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

K984323 is the FDA 510(k) clearance record for ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05, 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 one recall naming K984323.

Clearance record

Decision date
Received
(12 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 9500 Jeronimo Rd., Irvine CA
510(k) summary
Summary
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJX, 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