The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Dsdna Antibody Elisa.
| Device ID | K101319 |
| 510k Number | K101319 |
| Device Name: | IMMULISA DSDNA ANTIBODY ELISA |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120 |
| Contact | Kevin Lawson |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-05-11 |
| Decision Date | 2010-12-09 |