The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl 17a-oh Progersterone (dsl #6800).
| Device ID | K894265 |
| 510k Number | K894265 |
| Device Name: | DSL 17A-OH PROGERSTERONE (DSL #6800) |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Johnny Willis |
| Correspondent | Johnny 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 | 1989-06-22 |
| Decision Date | 1989-09-07 |