The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for C-terminal Pth Ria Kit.
Device ID | K853784 |
510k Number | K853784 |
Device Name: | C-TERMINAL PTH RIA KIT |
Classification | Radioimmunoassay, Parathyroid Hormone |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Contact | Gopal Savjani |
Correspondent | Gopal Savjani DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Product Code | CEW |
CFR Regulation Number | 862.1545 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-09 |
Decision Date | 1985-10-04 |