Amerlite Tbg Assay, LAN.0005/1005 240/144 Test Kit

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

510(k) Number

K893469 ↗

FDA Product Code

CEE

Device Class

Class II

Regulation

21 CFR Part 862.1685

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Amerlite Tsh Assay, LAN.0001/2001 240 & 144 Kit

  Class II

  FDA 510(k) K882907 Active Cleared 22 Sep 1988

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  Class I

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• Amerlite Fsh Assay, LAN.0077/2077 240 and 144 Test

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  Class I

  FDA 510(k) K800740 Active Cleared 16 Apr 1980

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  Class II

  FDA 510(k) K812236 Active Cleared 9 Sep 1981

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