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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