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510(k) K953662

FIRST CHOICE KETONES URINE TEST STRIPS by Polymer Technology Intl. — Product Code JIN

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
Nitroprusside, Ketones (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1435
Review Panel
CH
Submission Type

Other clearances by Polymer Technology Intl.

  • K953672 — FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS (July 1, 1996)
  • K953661 — FIRST CHOICE GLUCOSE URINE TEST STRIPS (June 14, 1996)
  • K953680 — FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS (June 12, 1996)
  • K946166 — FIRST CHOICE(TM) TEST STRIP (November 8, 1995)
  • K950628 — FIRST CHOICE TEST STRIP (November 8, 1995)

Other clearances for product code JIN

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  • K192957 — VivaChek Blood Glucose and B-Ketone Monitoring System (June 5, 2020)
  • K182593 — KET-1 Blood Ketone Monitoring System (December 18, 2018)
  • K173345 — TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System (May 4, 2018)
  • K170463 — KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitor (April 13, 2018)
  • K170587 — On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips f (July 6, 2017)
  • K060768 — PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS (April 21, 2006)
  • K033114 — KETOCHECKS (April 26, 2004)
  • K003987 — URS-1K (KETONE TESST) (April 26, 2001)
  • K953680 — FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS (June 12, 1996)