The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Anti-sci-70 Antibody Test.
| Device ID | K903314 |
| 510k Number | K903314 |
| Device Name: | ANTI-SCI-70 ANTIBODY TEST |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Contact | Krasny, Ph.d. |
| Correspondent | Krasny, Ph.d. IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-24 |
| Decision Date | 1990-08-14 |