510(k) K042641
K042641 is an FDA 510(k) premarket notification submitted by Cenogenics Corp. for the device "CHEMVIEW-10". The FDA issued a decision of Substantially Equivalent on January 7, 2005. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Cenogenics Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2005
- Date Received
- September 27, 2004
- 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