The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Axsym Progesterone.
| Device ID | K955025 |
| 510k Number | K955025 |
| Device Name: | AXSYM PROGESTERONE |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT MALL Buffalo, NY 14225 |
| Contact | Joy C Sonsalla |
| Correspondent | Joy C Sonsalla ABBOTT LABORATORIES 100 ABBOTT MALL Buffalo, NY 14225 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-02 |
| Decision Date | 1996-03-07 |
| Summary: | summary |