The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Enhanced Rna Pol Iii Antibody Elisa.
| Device ID | K172078 |
| 510k Number | K172078 |
| Device Name: | ImmuLisa Enhanced RNA POL III Antibody ELISA |
| Classification | Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody |
| Applicant | IMMCO Diagnostics, Inc. 60 Pineview Dr. Buffalo, NY 14228 |
| Contact | Kevin Lawson |
| Correspondent | Kevin Lawson IMMCO Diagnostics, Inc. 60 Pineview Dr. Buffalo, NY 14228 |
| Product Code | NYO |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-10 |
| Decision Date | 2018-03-30 |
| Summary: | summary |