510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934068Substantially Equivalent

Beckman Direct Bilirubin Reagent

Beckman-Diagnostic Systems Group, Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934068 is the FDA 510(k) clearance record for BECKMAN DIRECT BILIRUBIN REAGENT, a class II device, cleared for Beckman-Diagnostic Systems Group on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 11 510(k) clearances for Beckman-Diagnostic Systems Group, from to . As of , FDA records show one recall naming K934068.

Clearance record

Decision date
Received
(249 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Beckman-Diagnostic Systems Group 200 S. Kraemer Blvd., Brea CA
510(k) summary
Statement
Third party review
No

Clearances, product code CIG

Trailing 12 months
1 clearance under product code CIG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260