The following data is part of a premarket notification filed by Sen Tech Medical Corp. with the FDA for Chem Pro 1000 Chemistry Analysis.
| Device ID | K851100 |
| 510k Number | K851100 |
| Device Name: | CHEM PRO 1000 CHEMISTRY ANALYSIS |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | SEN TECH MEDICAL CORP. 3771 LEXINGTON AVE. Arden Hills, MN 55112 |
| Contact | Walter L Sembrowich |
| Correspondent | Walter L Sembrowich SEN TECH MEDICAL CORP. 3771 LEXINGTON AVE. Arden Hills, MN 55112 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-19 |
| Decision Date | 1985-07-09 |