Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| AESKULISA® Jo-1 | 3113 | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289500555 |
| AESKULISA® U1-70 | 7104US | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289502948 |
| AESKULISA® Scl-70 | 7111US | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289502993 |
| AESKULISA® Scl-70 | 3111 | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289500531 |
| AESKULISA® Sm | 3106 | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289500487 |
| AESKULISA® U1-70 | 3104 | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289500463 |
| AESKULISA® ANA-8Pro | 3101 | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289500425 |
| AESKULISA® ENA-6Pro | 3103 | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289500456 |
| AESKULISA® ENA-6Pro | 7103US | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289502931 |
| AESKULISA® Jo-1 | 7113US | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289503013 |
| AESKULISA® SS-B | 7110US | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289502986 |
| ENA-6Pro ELISA | 35-E6PHU-E01 | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | LJM | B24235E6PHUE010 |
| ANA-8Pro ELISA | 35-ANAHU-E01 | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | LJM | B24235ANAHUE010 |
| AESKULISA® ANA-8Pro | 7101US | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289502917 |
| AESKULISA® Sm | 7106US | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289502962 |
| AESKULISA® SS-B | 3110 | Aesku.Diagnostics GmbH & Co. KG | LJM | 04250289500524 |