The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Autoantibody Test System (mouse Kidney/stomach).
| Device ID | K883915 |
| 510k Number | K883915 |
| Device Name: | AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, 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 | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-16 |
| Decision Date | 1988-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845714004193 | K883915 | 000 |
| 00845714003547 | K883915 | 000 |
| 00845714003363 | K883915 | 000 |
| 00845714003332 | K883915 | 000 |
| 00845714002861 | K883915 | 000 |
| 00845714001994 | K883915 | 000 |
| 00845714001987 | K883915 | 000 |
| 00845714001918 | K883915 | 000 |
| 00845714001895 | K883915 | 000 |