Elecsys Ca 125II on the Elecsys 1010

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K980240 ↗

FDA Product Code

LTK

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K902569 Active Cleared 9 Aug 1990

• Precimat Glycerol

  Class I

  FDA 510(k) K780439 Active Cleared 18 Apr 1978

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  Class II

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• Stattek Bun

  Class II

  FDA 510(k) K792328 Active Cleared 18 Dec 1979

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  Class II

  FDA 510(k) K931258 Active Cleared 10 Feb 1994

See all devices from Boehringer Mannheim Corp. →