The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Lh Irma.
| Device ID | K961109 |
| 510k Number | K961109 |
| Device Name: | ACTIVE LH IRMA |
| Classification | Radioimmunoassay, Luteinizing 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 | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-20 |
| Decision Date | 1996-04-05 |
| Summary: | summary |