510(k) K940043
K940043 is an FDA 510(k) premarket notification submitted by Bioscan Instruments, Inc. for the device "BIOSCAN REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on April 12, 1994. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Bioscan Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1994
- Date Received
- January 5, 1994
- 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