510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033056Substantially Equivalent

Bun Reagent for Beckman Synchron Cx & Cx Delta Reagent

DIAMOND DIAGNOSTICS Inc, Holliston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033056 is the FDA 510(k) clearance record for BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT, a class II device, cleared for Diamond Diagnostics, Inc. on under FDA product code CDS (Electrode, Ion Specific, Urea Nitrogen). FDA records list 26 510(k) clearances for Diamond Diagnostics, Inc., from to . As of , FDA records show no recalls naming K033056.

Clearance record

Decision date
Received
(123 days to decision)
Product code
CDS Electrode, Ion Specific, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diamond Diagnostics, Inc. 331 Fiske St., Holliston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CDS

Trailing 12 months

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

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