Ciba Corning Acs Estradiol-6 Assay

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K954697 ↗

FDA Product Code

CHP

Device Class

Class I

Regulation

21 CFR Part 862.1260

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K864132 Active Cleared 16 Dec 1986

• Gilford Uniqual Abnormal Control Serum/Unassayed

  Class I

  FDA 510(k) K860998 Active Cleared 3 Apr 1986

• Acs FRT4 Immunoassay

  Class I

  FDA 510(k) K961510 Active Cleared 17 Jun 1996

• Ciba Corning Certain Lyte

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  FDA 510(k) K894576 Active Cleared 30 Oct 1989

• Ciba Corning ACS;180 Dpd Assay

  Class I

  FDA 510(k) K963251 Active Cleared 15 Oct 1996

• Ciba Corning Magic Lite Chlamydia Immunoassay

  Class I

  FDA 510(k) K895122 Active Cleared 30 Oct 1989

See all devices from Ciba Corning Diagnostics Corp. →