The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for C-terminal Pth Ria Test Kit, Dsl-1000.
Device ID | K813203 |
510k Number | K813203 |
Device Name: | C-TERMINAL PTH RIA TEST KIT, DSL-1000 |
Classification | Radioimmunoassay, Parathyroid Hormone |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CEW |
CFR Regulation Number | 862.1545 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-13 |
Decision Date | 1981-12-03 |