The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Dhea-s-7.
Device ID | K962895 |
510k Number | K962895 |
Device Name: | DSL DHEA-S-7 |
Classification | Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
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 | JKC |
CFR Regulation Number | 862.1245 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-25 |
Decision Date | 1996-09-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15099590211509 | K962895 | 000 |