510(k) K020935
K020935 is an FDA 510(k) premarket notification submitted by Hemocue, Inc. for the device "HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706". The FDA issued a decision of Substantially Equivalent on April 3, 2002. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Hemocue, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2002
- Date Received
- March 22, 2002
- Clearance Type
- Special
- 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