The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Anti-ss-a (ro) And Anti-ss-b (la) Antibody Test.
| Device ID | K895339 |
| 510k Number | K895339 |
| Device Name: | ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Contact | Russell Nisengard |
| Correspondent | Russell Nisengard 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 | 1989-08-31 |
| Decision Date | 1989-10-04 |