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510(k) K946166

FIRST CHOICE(TM) TEST STRIP by Polymer Technology Intl. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1995
Date Received
December 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Polymer Technology Intl.

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  • K953662 — FIRST CHOICE KETONES URINE TEST STRIPS (June 14, 1996)
  • K953680 — FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS (June 12, 1996)
  • K950628 — FIRST CHOICE TEST STRIP (November 8, 1995)

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