The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Axsym Follicle Stimulating Hormone (fsh).
| Device ID | K935612 |
| 510k Number | K935612 |
| Device Name: | AXSYM FOLLICLE STIMULATING HORMONE (FSH) |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. D389, AP30 Abbott Park, IL 60064 |
| Contact | Joy C Sonsalla |
| Correspondent | Joy C Sonsalla ABBOTT LABORATORIES ONE ABBOTT PARK RD. D389, AP30 Abbott Park, IL 60064 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-22 |
| Decision Date | 1994-06-21 |