Resubmitted Modified Rubalex

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K901637 ↗

FDA Product Code

LQN

Device Class

Class II

Regulation

21 CFR Part 866.3510

Advisory Committee

Microbiology

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

See all devices from Orion Corp. →