The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Axsym Intact Pth, Model 2g06.
| Device ID | K020945 |
| 510k Number | K020945 |
| Device Name: | AXSYM INTACT PTH, MODEL 2G06 |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Carroll Potts |
| Correspondent | Carroll Potts DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | CEW |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-25 |
| Decision Date | 2002-05-31 |
| Summary: | summary |