The following data is part of a premarket notification filed by Sentech Medical Corp. with the FDA for Chem-pro 1000 Clinical Chemistry-analysis Sys.
Device ID | K855091 |
510k Number | K855091 |
Device Name: | CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS |
Classification | Electrode, Ion Specific, Urea Nitrogen |
Applicant | SENTECH MEDICAL CORP. 3771 LEXINGTON AVE. Arden Hills, MN 55126 |
Contact | Walter L Sembrowich |
Correspondent | Walter L Sembrowich SENTECH MEDICAL CORP. 3771 LEXINGTON AVE. Arden Hills, MN 55126 |
Product Code | CDS |
CFR Regulation Number | 862.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-20 |
Decision Date | 1986-03-14 |