Ciba Corning 300 Series System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K933373 ↗

FDA Product Code

JGS

Device Class

Class II

Regulation

21 CFR Part 862.1665

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ciba Corning Magic(R) Lite Tu Immunoassay

  Class II

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• Gilford Uniqual Abnormal Control Serum/Unassayed

  Class I

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• Acs FRT4 Immunoassay

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• Ciba Corning ACS;180 Dpd Assay

  Class I

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• 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. →