510(k) K081251
- Device
- MODIFICATION TO AESKULISA DS DNA G
- Applicant
- AESKU.DIAGNOSTICS
- 510(k) number
- K081251
- Product code
- LSW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-05-13
- Date received
- 2008-05-02
- Regulation
- 866.5100
- Classification name
- Anti-dna Antibody, Antigen And Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- SASCHA PFEIFFER
- Address
- Mikroforum Ring 2 Wendelsheim, Rheinland DE D-55234 D-55234
FDA Registration Numbers#
- 8043792
- 2026994
- 3039353646
- 1222302
- 3004973408
- 3003935253
- 3003825930
- 9610566
Source Documents#
Other 510(k) Records For Product Code LSW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 | Aesku.Diagnostics GmbH & Co. KG | 2018-02-16 |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | Inova Diagnostics, Inc. | 2016-04-11 |
| K072393 | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 | Phadia US, Inc. | 2007-12-07 |
| K060380 | FIDIS DSDNA | Biomedical Diagnostics (Bmd) SA | 2006-05-02 |
| K041628 | AESKULISA DS DNA G | Aesku Diagnostics | 2004-10-14 |
| K921658 | ANTI-DSDNA ANTIBODY TEST | Immco Diagnostics, Inc. | 1993-03-22 |
| K872085 | THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS | Immunodiagnostics, Ltd. | 1987-09-01 |
Legacy Summary#
summary
FDA Review#
Decision Summary