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JBD — System, Analysis, Electrophoretic Hemoglobin Class II

FDA Device Classification

Classification Details

Product Code
JBD
Device Class
Class II
Regulation Number
864.7440
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K053571interlabMICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBJune 30, 2006
K032862interlabINTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMFebruary 3, 2004
K992199helena laboratoriesACID HEMOGLOBIN KITSeptember 21, 1999
K991362moraxHYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), AJune 21, 1999
K982426helena laboratoriesSPIFE ALKALINE HEMOGLOBINDecember 17, 1998
K931503helena laboratoriesREP HEMOGLOBIN IEF KITS (CAT. NO. 3250)August 16, 1993
K931465helena laboratoriesREP ALKALINE HB-15 #3196,-8 #3197,-4 3198July 6, 1993
K901143helena laboratoriesREP HEMOGLOBIN IEF KITS (CAT. NO. 3250)May 23, 1990
K830804corning medical and scientificLABILE REMOVING HEMOLYZING REAGENTMay 4, 1983
K820518gelman sciencesGELMAN GLYCO-PHORE BUFFERApril 9, 1982
K813395helena laboratoriesCELLULOSE ACETATE-CITRATE AGAR HEMOGLODecember 31, 1981
K810919isolabHEMOGLOBIN ELECTROPHORESIS CONTROLApril 23, 1981
K810047gelman sciencesAUTOPHOR 128February 5, 1981
K802884corning medical and scientificCORNING NORMAL GLYCOSYLATED HEMOGLOBINDecember 22, 1980
K802821beckman instrumentsPARAGON HEMOGLOBIN ELECTRO. REAG. KITDecember 11, 1980
K800855helena laboratoriesA,FSC LYOPHILIZED HEMO CONTROLApril 29, 1980
K800853helena laboratoriesA,SA2 LYOPHILIZED HEMO CONTROLApril 29, 1980
K800856helena laboratoriesA,FDA2 LYOPHILIZED HEMO CONTROLApril 29, 1980
K800854helena laboratoriesA,A2 LYOPHILIZED HEMO CONTROLApril 29, 1980
K791290beckman instrumentsBECKMAN B-4 TEB BUFFER KITAugust 3, 1979