Coat-A-Count Neonatal T4 Kit Ria Kit

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K831107 ↗

FDA Product Code

CDX

Device Class

Class II

Regulation

21 CFR Part 862.1700

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K991797 Active Cleared 9 Jun 1999

• Coat-A-Count T4 Ria Kit

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  FDA 510(k) K811315 Active Cleared 27 May 1981

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  FDA 510(k) K954755 Active Cleared 29 Nov 1995

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