The following data is part of a premarket notification filed by Cis-us, Inc. with the FDA for Elsa-pth.
| Device ID | K950211 |
| 510k Number | K950211 |
| Device Name: | ELSA-PTH |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | CIS-US, INC. 10 DE ANGELO DR. Bedford, MA 01730 |
| Contact | Mary E Donovan |
| Correspondent | Mary E Donovan CIS-US, INC. 10 DE ANGELO DR. Bedford, MA 01730 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-19 |
| Decision Date | 1995-04-13 |