The following data is part of a premarket notification filed by Aesku.diagnostics with the FDA for Aeskulisa Dgp-a, Aeskulisa Dgp-g,aeskulisa Dgp-check.
| Device ID | K132082 |
| 510k Number | K132082 |
| Device Name: | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK |
| Classification | Antibodies, Gliadin |
| Applicant | AESKU.DIAGNOSTICS MIKROFORUM RING 2 Wendelsheim, DE D-55234 |
| Contact | Sascha Pfeiffer |
| Correspondent | Sascha Pfeiffer AESKU.DIAGNOSTICS MIKROFORUM RING 2 Wendelsheim, DE D-55234 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-05 |
| Decision Date | 2013-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250289504843 | K132082 | 000 |
| 04250289504591 | K132082 | 000 |
| 04250289504584 | K132082 | 000 |
| 04250289503679 | K132082 | 000 |
| 04250289503631 | K132082 | 000 |
| 04250289503624 | K132082 | 000 |