510(k) K190675
K190675 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "Dimension EXL High-Sensitivity Troponin I (TNIH) Assay". The FDA issued a decision of Substantially Equivalent on May 17, 2019. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2019
- Date Received
- March 15, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoassay Method, Troponin Subunit
- Device Class
- Class II
- Regulation Number
- 862.1215
- Review Panel
- CH
- Submission Type