Formulations, Paraffin, All

FDA product code KEO · Class I (low risk) · 21 CFR 864.4010 · Pathology

11510(k) clearances
0PMA approvals
3recalls
GMP exemptexempt from GMP rules

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K893772Tissue Embedding MediumKEO · Traditional Stephens Scientific06/22/1989SE
K862223Micro Thin* ParaffinKEO · Traditional Richard-Allan Medical Ind., Inc.06/17/1986SE
K862141Histology ParaffinKEO · Traditional Erie Scientific Co.06/13/1986SE
K861270Blue Ribbon Paraffin Infiltration/Embedding Med.KEO · Traditional Surgipath Medical Industries, Inc.04/11/1986SE
K842053Paraplast Extra Tissue Embedding Med.KEO · Traditional Sherwood Medical Co.06/26/1984SE
K833071Technicon ParacutKEO · Traditional Technicon Instruments Corp.10/14/1983SE
K831580Paraffin Infiltration MediumKEO · Traditional Surgipath Medical Industries, Inc.06/17/1983SE
K812191Vaspar SealentKEO · Traditional American Scientific Products08/31/1981SE
K810568Paraffin Embedding MediumKEO · Traditional Surgipath Medical Industries, Inc.03/17/1981SE
K803241Histological Embedding MediaKEO · Traditional Miles Laboratories, Inc.01/28/1981SE
K760602Sorvall Embedding MediumKEO · Traditional E.I. Dupont DE Nemours & Co., Inc.09/21/1976SE

Recalls

RecallProductFirmInitiated
Z-1748-2014 Class IITissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use.…This Lot has variations in melting temperature. Sakura Finetek USA Inc04/16/2014Terminated
Z-1148-2010 Paraffin Pretreatment Reagent Kit III; each kit contains the following: 5 x 50 mL…The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their… Abbott Molecular01/22/2010Terminated
Z-1147-2010 Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL…The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their… Abbott Molecular01/22/2010Terminated