The following data is part of a premarket notification filed by Mbl International Corporation with the FDA for Anti Rna Polymerase Iii Elisa Kit, Model 7805.
| Device ID | K060431 |
| 510k Number | K060431 |
| Device Name: | ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 |
| Classification | Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody |
| Applicant | MBL INTERNATIONAL CORPORATION PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MBL INTERNATIONAL CORPORATION PO BOX 7007 Deerfield, IL 60015 |
| Product Code | NYO |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-21 |
| Decision Date | 2006-06-19 |
| Summary: | summary |