The following data is part of a premarket notification filed by Aesku Diagnostics with the FDA for Aeskuslides Ana Hep-2.
| Device ID | K120889 |
| 510k Number | K120889 |
| Device Name: | AESKUSLIDES ANA HEP-2 |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | AESKU DIAGNOSTICS 87 PEDRICKTOWN-WOODSTOWN RD. Pedricktown, NJ 08067 |
| Contact | Helene Paxton |
| Correspondent | Helene Paxton AESKU DIAGNOSTICS 87 PEDRICKTOWN-WOODSTOWN RD. Pedricktown, NJ 08067 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-23 |
| Decision Date | 2012-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250289504935 | K120889 | 000 |
| 04250289504461 | K120889 | 000 |
| 04250289503501 | K120889 | 000 |
| 04250289503020 | K120889 | 000 |
| 04250289500579 | K120889 | 000 |
| 04250289500005 | K120889 | 000 |