The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Modified Calcitonin Ria Kit Dsl #1200.
| Device ID | K874087 |
| 510k Number | K874087 |
| Device Name: | MODIFIED CALCITONIN RIA KIT DSL #1200 |
| 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 | 1987-10-07 |
| Decision Date | 1988-02-02 |