First Choice Test Strip

by Polymer Technology Intl. 510(k)

Active United States

510(k) K950628

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK950628	Date8 Nov 1995Cleared	StatusActive

Coverage

1 jurisdiction

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Withdrawn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: K950628
FDA Product Code: CGA

Device Class: Class II
Regulation: 21 CFR Part 862.1345
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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