The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Calcitonin Ria Test Kit, Dls 1200.
| Device ID | K821675 |
| 510k Number | K821675 |
| Device Name: | CALCITONIN RIA TEST KIT, DLS 1200 |
| Classification | Radioimmunoassay, Calcitonin |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JKR |
| CFR Regulation Number | 862.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-08 |
| Decision Date | 1982-06-22 |