510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023764Substantially Equivalent

Unicel Dxi 800 Access Immunoassay System, Model 973100

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

K023764 is the FDA 510(k) clearance record for UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100, a class I device, cleared for Beckman Coulter, Inc. on under FDA product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show 31 recalls naming K023764.

Clearance record

Decision date
Received
(77 days to decision)
Product code
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Regulation
21 CFR 862.2160
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Beckman Coulter, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JJE

Trailing 12 months

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

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