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First Choice Glucose Urine Test Strips

by Polymer Technology Intl. 510(k)

Active United States

510(k) K953661

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK953661 Date14 Jun 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JIL
Device Class
Class II
Regulation
21 CFR Part 862.1340
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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