Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version)

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K060578 ↗

FDA Product Code

JKR

Device Class

Class II

Regulation

21 CFR Part 862.1140

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Scantibodies Laboratory Tsh Immunoradiometric Assay (Irma)(Coated Tube Technology)

  Class II

  FDA 510(k) K962464 Active Cleared 8 Oct 1996

• Syscos Idc - G, Idc, Bsc, Idc - G

  Class I

  FDA 510(k) K974262 Active Cleared 24 Dec 1997

See all devices from Scantibodies Laboratory Inc. →