510(k) K971145
K971145 is an FDA 510(k) premarket notification submitted by Gds Technology, LLC for the device "GLUCOSITE TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on September 17, 1997. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Gds Technology, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 1997
- Date Received
- March 28, 1997
- 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