The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Anti-ena Antibody Test Kit.
| Device ID | K920386 |
| 510k Number | K920386 |
| Device Name: | ANTI-ENA ANTIBODY TEST KIT |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Contact | Susan Krasny |
| Correspondent | Susan Krasny 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 | 1992-01-30 |
| Decision Date | 1992-03-30 |