Lifesign Mi Myoglobin

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K942052 ↗

FDA Product Code

DDR

Device Class

Class II

Regulation

21 CFR Part 866.5680

Advisory Committee

Immunology

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

• Biostix I. Hcg - One Step Pregnancy Test

  Class II

  FDA 510(k) K894750 Active Cleared 18 Oct 1989

See all devices from Princeton Biomedix →