510(k) K880585
K880585 is an FDA 510(k) premarket notification submitted by Mach Diag. C/O Wichita State University for the device "DEXPAD, BLOOD GLUCOSE STRIP". The FDA issued a decision of Substantially Equivalent on April 18, 1988. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Mach Diag. C/O Wichita State University has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1988
- Date Received
- February 10, 1988
- 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