510(k) K953672

FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS by Polymer Technology Intl. — Product Code JMT

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