The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active Non-extraction Igf-i Irma.
Device ID | K961172 |
510k Number | K961172 |
Device Name: | DSL ACTIVE NON-EXTRACTION IGF-I IRMA |
Classification | Radioimmunoassay, Human Growth Hormone |
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 | CFL |
CFR Regulation Number | 862.1370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-25 |
Decision Date | 1996-04-23 |
Summary: | summary |