510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053090Substantially Equivalent

Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin Calibrator

Siemens Healthcare Diagnostics Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053090 is the FDA 510(k) clearance record for DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code JFM (Enzymatic Method, Bilirubin). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K053090.

Clearance record

Decision date
Received
(44 days to decision)
Product code
JFM Enzymatic Method, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110, Brea CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JFM

Trailing 12 months

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

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