The following data is part of a premarket notification filed by Kmi Diagnostics, Inc. with the FDA for Calcitonin.
| Device ID | K990073 |
| 510k Number | K990073 |
| Device Name: | CALCITONIN |
| Classification | Radioimmunoassay, Calcitonin |
| Applicant | KMI DIAGNOSTICS, INC. 373 280TH ST. Osceola, WI 54020 |
| Contact | Gottfried Kellerman |
| Correspondent | Gottfried Kellerman KMI DIAGNOSTICS, INC. 373 280TH ST. Osceola, WI 54020 |
| Product Code | JKR |
| CFR Regulation Number | 862.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-11 |
| Decision Date | 1999-05-11 |