The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active Beta2-microglobulin (dsl 6500).
Device ID | K915508 |
510k Number | K915508 |
Device Name: | DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500) |
Classification | System, Test, Beta-2-microglobulin Immunological |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Contact | Johnny R Willis |
Correspondent | Johnny R Willis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Product Code | JZG |
CFR Regulation Number | 866.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-09 |
Decision Date | 1992-03-17 |