The following data is part of a premarket notification filed by Aesku, Inc with the FDA for Aeskulisa Ttg A And Aeskulisa Ttg G.
| Device ID | K042644 |
| 510k Number | K042644 |
| Device Name: | AESKULISA TTG A AND AESKULISA TTG G |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | AESKU, INC 8880 NORTHWEST 18TH TERRACE Miami, FL 33172 |
| Contact | Stanley Ammons |
| Correspondent | Stanley Ammons AESKU, INC 8880 NORTHWEST 18TH TERRACE Miami, FL 33172 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2005-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817018343 | K042644 | 000 |
| 00847817018336 | K042644 | 000 |
| 04250289503136 | K042644 | 000 |
| 04250289503129 | K042644 | 000 |
| 04250289502887 | K042644 | 000 |
| 04250289502870 | K042644 | 000 |
| B24235TGGHUE010 | K042644 | 000 |
| B24235TGAHUE010 | K042644 | 000 |