The following data is part of a premarket notification filed by Solarcare Technologies Corp,inc. with the FDA for Stc Diagnostics Lsd Micro-plate Eia.
Device ID | K954073 |
510k Number | K954073 |
Device Name: | STC DIAGNOSTICS LSD MICRO-PLATE EIA |
Classification | Radioimmunoassay, Lsd (125-i) |
Applicant | SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
Contact | R. Sam Niedbala |
Correspondent | R. Sam Niedbala SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
Product Code | DLB |
CFR Regulation Number | 862.3580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-30 |
Decision Date | 1995-11-29 |