The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Abbott Axsym Prolactin(modification).
| Device ID | K953657 |
| 510k Number | K953657 |
| Device Name: | ABBOTT AXSYM PROLACTIN(MODIFICATION) |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | ABBOTT MFG., INC. 200 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Contact | Joy C Sonsalla |
| Correspondent | Joy C Sonsalla ABBOTT MFG., INC. 200 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Product Code | CFT |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-18 |
| Decision Date | 1995-09-25 |