510(k) K042189
K042189 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME SODIUM ENZYMATIC ASSAY". The FDA issued a decision of Substantially Equivalent on October 7, 2004. The device falls under product code MZU (System, Test, Sodium, Enzymatic Method), a Class II device regulated under 21 CFR 862.1665. Diazyme Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2004
- Date Received
- August 12, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Sodium, Enzymatic Method
- Device Class
- Class II
- Regulation Number
- 862.1665
- Review Panel
- CH
- Submission Type