Biostix I. Hcg - One Step Pregnancy Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K894750 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Biostix (Tm)Hcg--Simple Pregnancy Test

  Class II

  FDA 510(k) K892654 Active Cleared 19 Jun 1989

• Test, Lactate Dehydrogenase

  Class II

  FDA 510(k) K760345 Active Cleared 27 Oct 1976

• Biosign Hcg-One Step Pregnancy Test

  Class II

  FDA 510(k) K901011 Active Cleared 4 May 1990

• Alkaline Phosphatase (Alp)/Pnpp

  Class II

  FDA 510(k) K761315 Active Cleared 24 Feb 1977

• Biospot Hcg-Rapid Pregnancy Test

  Class II

  FDA 510(k) K894705 Active Cleared 18 Oct 1989

• Lifesign Mi Myoglobin

  Class II

  FDA 510(k) K942052 Active Cleared 7 Feb 1995

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