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510(k) K953661

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

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

Other clearances by Polymer Technology Intl.

  • K953672 — FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS (July 1, 1996)
  • K953662 — FIRST CHOICE KETONES 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)

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