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 |