510(k) K070704
K070704 is an FDA 510(k) premarket notification submitted by Drew Scientific, Inc. for the device "TRILOGY ANALYZER". The FDA issued a decision of Substantially Equivalent on July 13, 2007. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Drew Scientific, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2007
- Date Received
- March 13, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Oxidase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type