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 |