510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980855Substantially Equivalent

Immulite 2000 Carcinoembryonic Antigen (Cea) Kit

Siemens Healthcare Diagnostics Inc., Randolph NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980855 is the FDA 510(k) clearance record for IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT, a class II device, cleared for Dpc Cirrus on under FDA product code DHX (System, Test, Carcinoembryonic Antigen). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show one recall naming K980855.

Clearance record

Decision date
Received
(47 days to decision)
Product code
DHX System, Test, Carcinoembryonic Antigen
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Dpc Cirrus B13-B18, 111 Canfield Ave., Randolph NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DHX

Trailing 12 months

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

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