The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active 17a-oh Progesterone Ria (dsl 5000).
| Device ID | K943148 |
| 510k Number | K943148 |
| Device Name: | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Johnny R Willis |
| Correspondent | Johnny R Willis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | JLX |
| CFR Regulation Number | 862.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-30 |
| Decision Date | 1994-11-10 |