510(k) K090282
K090282 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific, Inc. for the device "QMS LIDOCAINE". The FDA issued a decision of Substantially Equivalent on May 29, 2009. The device falls under product code KLR (Enzyme Immunoassay, Lidocaine), a Class II device regulated under 21 CFR 862.3555. Thermo Fisher Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2009
- Date Received
- February 5, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Lidocaine
- Device Class
- Class II
- Regulation Number
- 862.3555
- Review Panel
- TX
- Submission Type