The following data is part of a premarket notification filed by Abbott Diagnostics Mfg., Inc. with the FDA for Acp.
| Device ID | K991010 |
| 510k Number | K991010 |
| Device Name: | ACP |
| Classification | Acid Phosphatase, Naphthyl Phosphate |
| Applicant | ABBOTT DIAGNOSTICS MFG., INC. 1920 HURD DR. Irving, TX 75038 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT DIAGNOSTICS MFG., INC. 1920 HURD DR. Irving, TX 75038 |
| Product Code | CKB |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-26 |
| Decision Date | 1999-05-19 |
| Summary: | summary |