The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active Afp Elisa, Model Dsl-10-8400.
| Device ID | K990138 |
| 510k Number | K990138 |
| Device Name: | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 |
| Classification | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| 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 | LOJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-06-21 |
| Summary: | summary |