510(k) K953672
K953672 is an FDA 510(k) premarket notification submitted by Polymer Technology Intl. for the device "FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS". The FDA issued a decision of Substantially Equivalent on July 1, 1996. The device falls under product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)), a Class I device regulated under 21 CFR 862.1510. Polymer Technology Intl. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 1996
- Date Received
- August 7, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- Device Class
- Class I
- Regulation Number
- 862.1510
- Review Panel
- CH
- Submission Type