The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl 1900 Active Human Growth Hormone Irma (dsl 1900).
Device ID | K970701 |
510k Number | K970701 |
Device Name: | DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) |
Classification | Radioimmunoassay, Human Growth Hormone |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Contact | Jonh Willis |
Correspondent | Jonh Willis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Product Code | CFL |
CFR Regulation Number | 862.1370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-26 |
Decision Date | 1997-04-02 |
Summary: | summary |