The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Buhlmann Vitamin B6 Rea.
| Device ID | K955561 |
| 510k Number | K955561 |
| Device Name: | BUHLMANN VITAMIN B6 REA |
| Classification | Radioassay, Vitamin B12 |
| Applicant | AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
| Contact | Richard E Conley |
| Correspondent | Richard E Conley AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
| Product Code | CDD |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-06 |
| Decision Date | 1996-05-23 |