Rheumelisa II Scl-70 Antibody Test Kit

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

510(k) Number

K930130 ↗

FDA Product Code

LLL

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Specimen Transport Medium

  Class I

  FDA 510(k) K935618 Active Cleared 21 Apr 1994

• Rf Stat Igm Test Kit

  Class II

  FDA 510(k) K920753 Active Cleared 30 Mar 1992

• Mumps Stat

  Class I

  FDA 510(k) K925209 Active Cleared 14 Oct 1994

• Biowhittaker 2001 Microplate Reader Firmware

  Class I

  FDA 510(k) K942245 Active Cleared 3 Apr 1995

• Biowhittaker Cartridge Software for Eia-400 Plate Reader

  Class I

  FDA 510(k) K942250 Active Cleared 4 Apr 1995

• Whitsoft

  Class I

  FDA 510(k) K942361 Active Cleared 4 Apr 1995

See all devices from Biowhittaker Molecular Applications, Inc. →