The following data is part of a premarket notification filed by Aesku.diagnostics with the FDA for Aeskulisa Glia A And Aeskulisa Glia G.
| Device ID | K052439 |
| 510k Number | K052439 |
| Device Name: | AESKULISA GLIA A AND AESKULISA GLIA G |
| Classification | Antibodies, Gliadin |
| Applicant | AESKU.DIAGNOSTICS 8880 NW 18TH TERRACE Miami, FL 33172 |
| Contact | Stanley Ammons |
| Correspondent | Stanley Ammons AESKU.DIAGNOSTICS 8880 NW 18TH TERRACE Miami, FL 33172 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-06 |
| Decision Date | 2006-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817018329 | K052439 | 000 |
| 00847817018312 | K052439 | 000 |
| 04250289503112 | K052439 | 000 |
| 04250289503105 | K052439 | 000 |
| 04250289502863 | K052439 | 000 |
| 04250289502856 | K052439 | 000 |
| 04250289501491 | K052439 | 000 |
| 04250289501484 | K052439 | 000 |