510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930898Substantially Equivalent

Radias Automated Immunoassay System

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

K930898 is the FDA 510(k) clearance record for RADIAS AUTOMATED IMMUNOASSAY SYSTEM, a class I device, cleared for Bio-Rad on under FDA product code JJI (Analyzer, Enzyme, For Clinical Use). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K930898.

Clearance record

Decision date
Received
(58 days to decision)
Product code
JJI Analyzer, Enzyme, For Clinical Use
Regulation
21 CFR 862.2500
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bio-Rad 4000 Alfred Nobel Dr., Hercules CA
510(k) summary
Statement
Third party review
No

Clearances, product code JJI

Trailing 12 months

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

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