The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Orgentec Anti-mpo (p-anca) Elisa.
| Device ID | K974701 |
| 510k Number | K974701 |
| Device Name: | ORGENTEC ANTI-MPO (P-ANCA) ELISA |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
| Contact | Richard Conley |
| Correspondent | Richard Conley AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-08 |
| Decision Date | 1998-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260157080188 | K974701 | 000 |
| 00404847435979 | K974701 | 000 |
| 04048474035971 | K974701 | 000 |
| 00840239035974 | K974701 | 000 |