510(k) K862301
K862301 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL SYSTEM 810, ACL AND THE REAGENT SETS". The FDA issued a decision of Substantially Equivalent on September 3, 1986. The device falls under product code GJA (Test, Thrombin Time), a Class II device regulated under 21 CFR 864.7875. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 1986
- Date Received
- June 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Thrombin Time
- Device Class
- Class II
- Regulation Number
- 864.7875
- Review Panel
- HE
- Submission Type