The following data is part of a premarket notification filed by Orgentec Diagnostika Gmbh with the FDA for Ana Detect.
| Device ID | K030929 |
| 510k Number | K030929 |
| Device Name: | ANA DETECT |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | ORGENTEC DIAGNOSTIKA GMBH 8201 CENTRAL AVE. NE, SUITE P Minneapolis, MN 55432 |
| Contact | Michael H Foley |
| Correspondent | Michael H Foley ORGENTEC DIAGNOSTIKA GMBH 8201 CENTRAL AVE. NE, SUITE P Minneapolis, MN 55432 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260157080638 | K030929 | 000 |
| 00404847435627 | K030929 | 000 |
| 00404847435634 | K030929 | 000 |
| 04048474035636 | K030929 | 000 |
| 04048474035629 | K030929 | 000 |
| 00840239035639 | K030929 | 000 |
| 00840239035622 | K030929 | 000 |
| 00840239041173 | K030929 | 000 |