510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980887Substantially Equivalent

Elecsys Cea on the Elecsys 1010

Boehringer Mannheim Corp., Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980887 is the FDA 510(k) clearance record for ELECSYS CEA ON THE ELECSYS 1010, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code DHX (System, Test, Carcinoembryonic Antigen). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K980887.

Clearance record

Decision date
Received
(112 days to decision)
Product code
DHX System, Test, Carcinoembryonic Antigen
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Boehringer Mannheim Corp. 4300 Hacienda Dr., Pleasanton CA
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