Myolex

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K863730 ↗

FDA Product Code

DDR

Device Class

Class II

Regulation

21 CFR Part 866.5680

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Rubalex

  Class II

  FDA 510(k) K852788 Active Cleared 12 Mar 1986

• Microalbuminuria Assay

  Class II

  FDA 510(k) K862671 Active Cleared 18 Sep 1986

• Oricult-N Culture-Paddle

  Class I

  FDA 510(k) K872058 Active Cleared 10 Jun 1987

• Immunochemical Assay Apolipoprotein B

  Class I

  FDA 510(k) K861882 Active Cleared 29 Oct 1986

• Chlamyset Antibody Eia

  Class I

  FDA 510(k) K864457 Active Cleared 11 Sep 1987

• Mamex Dc Mag MG12

  Class II

  FDA 510(k) K881506 Active Cleared 10 Jun 1988

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