FDA 510(k) Applications for Medical Device Product Code "JBD"
(System, Analysis, Electrophoretic Hemoglobin)

FDA 510(k) Number Applicant Device Name Decision Date
K992199 HELENA LABORATORIES ACID HEMOGLOBIN KIT 09/21/1999
K982426 HELENA LABORATORIES SPIFE ALKALINE HEMOGLOBIN 12/17/1998
K032862 INTERLAB S.R.L. INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM 02/03/2004
K053571 INTERLAB S.R.L. MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM 06/30/2006
K991362 MORAX HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) 06/21/1999


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