System, Analysis, Electrophoretic Hemoglobin

FDA product code JBD · Class II (moderate risk) · 21 CFR 864.7440 · Hematology

26510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K053571Microgel Alkaline Hemoglobin Electrophoresis Test System, Microgel Acid Hemoglobin…JBD · Traditional Interlab S.R.L.06/30/2006SE
K032862Interlab Alkaline Hemoglobin Electrophoresis Test SystemJBD · Traditional Interlab S.R.L.02/03/2004SE
K992199Acid Hemoglobin KitJBD · Traditional Helena Laboratories09/21/1999SE
K991362Hydragel Hemoglobin(E), Mini Hemoglobin(E), 7 Hemoglobin(E), 15 Hemoglobin(E), Acid(E)…JBD · Traditional Morax06/21/1999SE
K982426Spife Alkaline HemoglobinJBD · Traditional Helena Laboratories12/17/1998SE
K931503Rep Hemoglobin Ief Kits (Cat. No. 3250)JBD · Traditional Helena Laboratories08/16/1993SE
K931465Rep Alkaline HB-15 #3196,-8 #3197,-4 3198JBD · Traditional Helena Laboratories07/06/1993SE
K901143Rep Hemoglobin Ief Kits (Cat. No. 3250)JBD · Traditional Helena Laboratories05/23/1990SE
K830804Labile Removing Hemolyzing ReagentJBD · Traditional Corning Medical & Scientific05/04/1983SE
K820518Gelman Glyco-Phore BufferJBD · Traditional Gelman Sciences, Inc.04/09/1982SE
K813395Cellulose Acetate-Citrate Agar HemogloJBD · Traditional Helena Laboratories12/31/1981SE
K810919Hemoglobin Electrophoresis ControlJBD · Traditional Isolab, Inc.04/23/1981SE
K810047Autophor 128JBD · Traditional Gelman Sciences, Inc.02/05/1981SE
K802884Corning Normal Glycosylated HemoglobinJBD · Traditional Corning Medical & Scientific12/22/1980SE
K802821Paragon Hemoglobin Electro. Reag. KitJBD · Traditional Beckman Instruments, Inc.12/11/1980SE
K800856A,FDA2 Lyophilized Hemo ControlJBD · Traditional Helena Laboratories04/29/1980SE
K800855A,Fsc Lyophilized Hemo ControlJBD · Traditional Helena Laboratories04/29/1980SE
K800854A,A2 Lyophilized Hemo ControlJBD · Traditional Helena Laboratories04/29/1980SE
K800853A,SA2 Lyophilized Hemo ControlJBD · Traditional Helena Laboratories04/29/1980SE
K791290Beckman B-4 Teb Buffer KitJBD · Traditional Beckman Instruments, Inc.08/03/1979SE
K791008Eca (Special) Heme BufferJBD · Traditional Electrophoresis Corp. of America08/03/1979SE
K790944Citrate Agar Gel and Buffer SetJBD · Traditional Corning Medical & Scientific06/28/1979SE
K781119Eca Heme BufferJBD · Traditional Electrophoresis Corp. of America08/14/1978SE
K780807Hbf-Quiplate MethodologyJBD · Traditional Helena Laboratories06/02/1978SE
K780163Redi-Disc Hemoglobin Gel Tube KitJBD · Traditional Miles Laboratories, Inc.03/27/1978SE
K771649Hemoglobin A2 Testing SystemJBD · Traditional Isolab, Inc.10/07/1977SE

Recalls

RecallProductFirmInitiated
Z-0297-2020 Class IIISPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation…Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The… Helena Laboratories, Corp.02/27/2018Open, Classified
Z-0073-2007 HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique…The material used in packaging the product results in the presence of an additional artifact band above the… Sebia, Inc.08/29/2006Terminated