The following data is part of a premarket notification filed by Aesku. Systems Gmbh & Co. Kg with the FDA for Aeskuslides Ana Hep-2-gamma, Helios Fully Automated Ifa System.
| Device ID | K153117 |
| 510k Number | K153117 |
| Device Name: | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | AESKU. SYSTEMS GMBH & CO. KG MIKROFORUM RING 3 Wendelsheim, DE 55234 |
| Contact | Tom Stecklum |
| Correspondent | Rose Rainwater AESKU. SYSTEMS GMBH & CO. KG 95 Linden St. Suite 4 Oakland, CA 94607 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-28 |
| Decision Date | 2016-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250289512541 | K153117 | 000 |