510(k) K023885
K023885 is an FDA 510(k) premarket notification submitted by Analyticon Biotechnologies AG for the device "COMBI-SCREEN, MODELS 10SL AND 11SL". The FDA issued a decision of Substantially Equivalent on October 21, 2003. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Analyticon Biotechnologies AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2003
- Date Received
- November 21, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
- Device Class
- Class II
- Regulation Number
- 862.1340
- Review Panel
- CH
- Submission Type