510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981985Substantially Equivalent

Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209

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

K981985 is the FDA 510(k) clearance record for ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209, a class II device, cleared for Beckman Coulter, Inc. 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 K981985.

Clearance record

Decision date
Received
(111 days to decision)
Product code
DHX System, Test, Carcinoembryonic Antigen
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Beckman Coulter, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary
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