510(k) K030215
K030215 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "BIORAPID MONONUCLEOSIS". The FDA issued a decision of Substantially Equivalent on February 24, 2003. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2003
- Date Received
- January 21, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Infectious Mononucleosis
- Device Class
- Class II
- Regulation Number
- 866.5640
- Review Panel
- MI
- Submission Type