The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Sci-70 Antibody Elisa.
| Device ID | K113143 |
| 510k Number | K113143 |
| Device Name: | IMMULISA SCI-70 ANTIBODY ELISA |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120 |
| Contact | Kevin J Lawson |
| Correspondent | Bhavesh V Sheth INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-10-25 |
| Decision Date | 2011-12-02 |