Hematology Wright's Stain Pack

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833678 ↗

FDA Product Code

IAF

Device Class

Class I

Regulation

21 CFR Part 864.1850

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• J&S Iron Saturating Reagents

  Class I

  FDA 510(k) K893662 Active Cleared 20 Jul 1989

• Accutex Aso Latex Test

  Class I

  FDA 510(k) K924247 Active Cleared 7 Dec 1992

• J&S Uibc Reagents

  Class I

  FDA 510(k) K912717 Active Cleared 25 Sep 1991

• J&S Medical Sentry Urine Dipstick Control

  Class I

  FDA 510(k) K022085 Active Cleared 25 Jul 2002

• Accutex CRP Latex Test

  Class II

  FDA 510(k) K924332 Active Cleared 7 Dec 1992

• Eye Spot Im Test

  Class II

  FDA 510(k) K932688 Active Cleared 8 Sep 1993

See all devices from J.S. Medical Assoc. →