The following data is part of a premarket notification filed by Sen Tech Medical Corp. with the FDA for Chempro 1000.
| Device ID | K854260 |
| 510k Number | K854260 |
| Device Name: | CHEMPRO 1000 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | SEN TECH MEDICAL CORP. 3771 LEXINGTON AVE. Arden Hills, MN 55112 |
| Contact | Walter Sembrowich |
| Correspondent | Walter Sembrowich SEN TECH MEDICAL CORP. 3771 LEXINGTON AVE. Arden Hills, MN 55112 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-23 |
| Decision Date | 1985-11-19 |