Hematoxylin

FDA product code HYJ · Class I (low risk) · 21 CFR 864.1850 · Hematology

14510(k) clearances
0PMA approvals
1recalls
GMP exemptexempt from GMP rules

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K872500Anatech Hematoxylin-Extra StrengthHYJ · Traditional Anatech, Ltd.07/09/1987SE
K872499Anatech Hematoxylin-Normal StrengthHYJ · Traditional Anatech, Ltd.07/09/1987SE
K842740Delafield Hematoxylin StainHYJ · Traditional E K Ind., Inc.08/17/1984SE
K842741Gill Hematoxylin StainHYJ · Traditional E K Ind., Inc.08/15/1984SE
K831090Hematoxylin Gill Formulation IX#56016HYJ · Traditional Accra Laboratories, Inc.06/08/1983SE
K822352Hematoxylin Stain SolutionHYJ · Traditional Fisher Scientific Co., LLC08/16/1982SE
K821541Hematoxylin IIIHYJ · Traditional Volu Sol Medical Industries06/10/1982SE
K821540Hematoxylin IIHYJ · Traditional Volu Sol Medical Industries06/10/1982SE
K821533Hematoxylin IHYJ · Traditional Volu Sol Medical Industries06/10/1982SE
K821320Hematoxylin StainHYJ · Traditional Sigma Chemical Co.06/02/1982SE
K821062Hematoxylin SolutionHYJ · Traditional Sigma Chemical Co.04/29/1982SE
K811802HematoxylinHYJ · Traditional Richard-Allan Medical Ind., Inc.07/28/1981SE
K810759Gill's Hematoxylin #2HYJ · Traditional Surgipath04/14/1981SE
K810758Gill's Hematoxylin #1HYJ · Traditional Surgipath04/14/1981SE

Recalls

RecallProductFirmInitiated
Z-0738-2018 Class IHematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnosticIncreased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… Ventana Medical Systems Inc12/19/2017Terminated