510(k) K953661

FIRST CHOICE GLUCOSE URINE TEST STRIPS by Polymer Technology Intl. — Product Code JIL

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