510(k) K841575
K841575 is an FDA 510(k) premarket notification submitted by Sen Tech Medical Corp. for the device "SENTECH'S ULAB 1000 CLINICAL CHEM.". The FDA issued a decision of Substantially Equivalent on July 6, 1984. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Sen Tech Medical Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 1984
- Date Received
- April 17, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Potassium
- Device Class
- Class II
- Regulation Number
- 862.1600
- Review Panel
- CH
- Submission Type