The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Orgentec Anti-ss-a(ro) Elisa.
| Device ID | K962054 |
| 510k Number | K962054 |
| Device Name: | ORGENTEC ANTI-SS-A(RO) ELISA |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| 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 | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260157080058 | K962054 | 000 |
| 00404847435733 | K962054 | 000 |
| 04048474035735 | K962054 | 000 |
| 00840239035738 | K962054 | 000 |