The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Orgentec Anti-cardiolipin Elisa Assay.
| Device ID | K955449 |
| 510k Number | K955449 |
| Device Name: | ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY |
| Classification | System, Test, Anticardiolipin Immunological |
| 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 | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-29 |
| Decision Date | 1996-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260157080126 | K955449 | 000 |
| 00404847435870 | K955449 | 000 |
| 04048474035872 | K955449 | 000 |