The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl 5400 Active (tm) Ferritin Eia System.
| Device ID | K871489 |
| 510k Number | K871489 |
| Device Name: | DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Gopal Savjani |
| Correspondent | Gopal Savjani DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-15 |
| Decision Date | 1987-06-12 |