510(k) K073377
K073377 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)". The FDA issued a decision of Substantially Equivalent on May 4, 2008. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2008
- Date Received
- December 3, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Coagulation, Automated
- Device Class
- Class II
- Regulation Number
- 864.5400
- Review Panel
- HE
- Submission Type