The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Renin Irma.
| Device ID | K061758 |
| 510k Number | K061758 |
| Device Name: | ACTIVE RENIN IRMA |
| Classification | Radioimmunoassay, Angiotensin I And Renin |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Scott Bishop |
| Correspondent | Scott Bishop DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | CIB |
| CFR Regulation Number | 862.1085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-22 |
| Decision Date | 2006-07-28 |