The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Modification To Alkp.
| Device ID | K023807 |
| 510k Number | K023807 |
| Device Name: | MODIFICATION TO ALKP |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-14 |
| Decision Date | 2002-12-26 |
| Summary: | summary |