The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Antinuclear Antibody (ana) Test (mouse Liver Sect).
| Device ID | K883949 |
| 510k Number | K883949 |
| Device Name: | ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) |
| Classification | Antinuclear Antibody, Antigen, 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 | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-19 |
| Decision Date | 1988-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845714004339 | K883949 | 000 |
| 00845714004322 | K883949 | 000 |
| 00845714003448 | K883949 | 000 |
| 00845714003011 | K883949 | 000 |