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 |