The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active T4 Eia.
Device ID | K971269 |
510k Number | K971269 |
Device Name: | DSL ACTIVE T4 EIA |
Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Contact | John Willis |
Correspondent | John Willis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Product Code | KLI |
CFR Regulation Number | 862.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-04 |
Decision Date | 1997-05-22 |
Summary: | summary |