The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Inhibin-a Elisa, Model Dsl-10-28100.
Device ID | K002128 |
510k Number | K002128 |
Device Name: | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 |
Classification | Enzyme Immunoassay, Inhibin-a |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Contact | Michael (rusty) Nicar |
Correspondent | Michael (rusty) Nicar DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Product Code | NDR |
CFR Regulation Number | 862.1260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-14 |
Decision Date | 2000-12-05 |