FDA 510(k) Applications for Medical Device Product Code "MLE"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K991942 | COGENT DIAGNOTICS LTD. | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA | 08/24/1999 |
K010558 | INOVA DIAGNOSTICS, INC. | QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA | 04/03/2001 |