510(k) K953661
K953661 is an FDA 510(k) premarket notification submitted by Polymer Technology Intl. for the device "FIRST CHOICE GLUCOSE URINE TEST STRIPS". The FDA issued a decision of Substantially Equivalent on June 14, 1996. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Polymer Technology Intl. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 1996
- Date Received
- August 7, 1995
- 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