The following data is part of a premarket notification filed by Aesku Diagnostics Gmbh & Co. Kg with the FDA for Aeskuslides Ndna (crithidia Luciliae), Aeskuslides Ndna (crithidia Luciliae) Demo Kit, Aeskuslides Ndna (crithidia Luciliae) Bulk Kit X5, Aeskuslides Ndna (crithidia Luciliae) Bulk Kit X10.
| Device ID | K172348 |
| 510k Number | K172348 |
| Device Name: | AESKUSLIDES NDNA (Crithidia Luciliae), AESKUSLIDES NDNA (Crithidia Luciliae) Demo Kit, AESKUSLIDES NDNA (Crithidia Luciliae) Bulk Kit X5, AESKUSLIDES NDNA (Crithidia Luciliae) Bulk Kit X10 |
| Classification | Anti-dna Antibody, Antigen And Control |
| Applicant | Aesku Diagnostics GmbH & Co. KG Mikro-Forum-Ring 2 Wendeslheim, DE 55234 |
| Contact | Sandra Reuter |
| Correspondent | Sandra Reuter Aesku Diagnostics GmbH & Co. KG Mikro-Forum-Ring 2 Wendeslheim, DE 55234 |
| Product Code | LSW |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-03 |
| Decision Date | 2018-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250289510394 | K172348 | 000 |