The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Antinuclear Antibody (ana) Test (hep-2 Cells).
| Device ID | K883883 |
| 510k Number | K883883 |
| Device Name: | ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) |
| 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 | 1988-09-13 |
| Decision Date | 1988-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845714003530 | K883883 | 000 |
| 00845714000928 | K883883 | 000 |
| 00845714000904 | K883883 | 000 |
| 00845714000898 | K883883 | 000 |
| 00845714000881 | K883883 | 000 |
| 00845714000874 | K883883 | 000 |
| 00845714000867 | K883883 | 000 |
| 00845714000843 | K883883 | 000 |
| 00845714000836 | K883883 | 000 |
| 00845714000829 | K883883 | 000 |
| 00845714000249 | K883883 | 000 |
| 00845714000010 | K883883 | 000 |
| 00845714001932 | K883883 | 000 |
| 00845714001949 | K883883 | 000 |
| 00845714003479 | K883883 | 000 |
| 00845714003233 | K883883 | 000 |
| 00845714003226 | K883883 | 000 |
| 00845714003223 | K883883 | 000 |
| 00845714003219 | K883883 | 000 |
| 00845714002182 | K883883 | 000 |
| 00845714002120 | K883883 | 000 |
| 00845714002007 | K883883 | 000 |
| 00845714001970 | K883883 | 000 |
| 00845714001963 | K883883 | 000 |
| 00845714001956 | K883883 | 000 |
| 00845714000003 | K883883 | 000 |