The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Renin Irma Model Number Dsl-25100.
| Device ID | K981607 |
| 510k Number | K981607 |
| Device Name: | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 |
| Classification | Radioimmunoassay, Angiotensin I And Renin |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | John Class |
| Correspondent | John Class DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | CIB |
| CFR Regulation Number | 862.1085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-05 |
| Decision Date | 1998-05-27 |
| Summary: | summary |