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 |