510(k) K033360
K033360 is an FDA 510(k) premarket notification submitted by General Atomics for the device "DIAZYME LITHIUM ENZYMATIC ASSAY KIT". The FDA issued a decision of Substantially Equivalent on December 23, 2003. The device falls under product code JII (Atomic Absorption, Lithium), a Class II device regulated under 21 CFR 862.3560. General Atomics has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2003
- Date Received
- October 21, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Atomic Absorption, Lithium
- Device Class
- Class II
- Regulation Number
- 862.3560
- Review Panel
- TX
- Submission Type