The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Ultra-sensitive Calcitonin Ria (dsl 5200).
| Device ID | K914429 |
| 510k Number | K914429 |
| Device Name: | DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) |
| Classification | Radioimmunoassay, Calcitonin |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Johnny R Willis |
| Correspondent | Johnny R Willis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | JKR |
| CFR Regulation Number | 862.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-04 |
| Decision Date | 1992-01-15 |