The following data is part of a premarket notification filed by Sentech Medical Corp. with the FDA for Sentech's Ulab 1000 Clinical Chem..
| Device ID | K841575 |
| 510k Number | K841575 |
| Device Name: | SENTECH'S ULAB 1000 CLINICAL CHEM. |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | SENTECH MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-17 |
| Decision Date | 1984-07-06 |