510(k) K183176
K183176 is an FDA 510(k) premarket notification submitted by Spectral Medical, Inc. for the device "Endotoxin Activity Assay (EAA)". The FDA issued a decision of Substantially Equivalent on March 12, 2019. The device falls under product code NGS (Assay, Endotoxin Activity, Chemiluminescent), a Class II device regulated under 21 CFR 866.3210. Spectral Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2019
- Date Received
- November 16, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Endotoxin Activity, Chemiluminescent
- Device Class
- Class II
- Regulation Number
- 866.3210
- Review Panel
- MI
- Submission Type