Ptk Plus. Home Pregnancy Test

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

510(k) Number

K861946 ↗

FDA Product Code

LCX

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K874818 Active Cleared 28 Sep 1988

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  FDA 510(k) K850070 Active Cleared 22 Jan 1985

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  FDA 510(k) K881003 Active Cleared 18 May 1988

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• C&T Pregnancy Test Kit

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  FDA 510(k) K884489 Active Cleared 8 Mar 1989

• PTK Healthcheck Pregnancy Test Kit

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  FDA 510(k) K844281 Active Cleared 10 Dec 1984

See all devices from Healthcheck Corp. →