FIRST CHOICE GLUCOSE URINE TEST STRIPS— 510(k) K953661

Name: FDA 510(k) clearance K953661
Creator: U.S. Food and Drug Administration
Published: 1996-06-14

Substantially Equivalent

Polymer Technology Intl.

FDA 510(k) clearance K953661 for FIRST CHOICE GLUCOSE URINE TEST STRIPS, Substantially Equivalent on 1996-06-14. Applicant: Polymer Technology Intl.. Device class: 2.

Clearance details

Applicant: Polymer Technology Intl.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1995-08-07
Decision date: 1996-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Issaquah, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIL

view all

K193514 — AUTION MAX AX-4060 Urinalysis System2023-04-13
K183432 — cobas u 601 urinalysis test system2019-05-07
K173327 — DIP/U.S. Urine Analysis Test System2018-07-18
K180356 — inui In-Home Urine Analysis Test System2018-05-25
K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips2018-05-23

More clearances from Polymer Technology Intl.

view all

K953672 — FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS1996-07-01
K953662 — FIRST CHOICE KETONES URINE TEST STRIPS1996-06-14
K953680 — FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS1996-06-12
K946166 — FIRST CHOICE(TM) TEST STRIP1995-11-08
K950628 — FIRST CHOICE TEST STRIP1995-11-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.