510(k) K213426
K213426 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HemosIL ReadiPlasTin". The FDA issued a decision of Substantially Equivalent on August 16, 2022. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2022
- Date Received
- October 21, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Time, Prothrombin
- Device Class
- Class II
- Regulation Number
- 864.7750
- Review Panel
- HE
- Submission Type