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FDA 510(k)

FIRST CHOICE GLUCOSE URINE TEST STRIPS

K-Number: K953661 · 1996-06-14

ApplicantPolymer Technology Intl.
Decision Date1996-06-14
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FIRST CHOICE GLUCOSE URINE TEST STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Intl.. It received FDA 510(k) clearance on 1996-06-14 under 510(k) number K953661. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRST CHOICE GLUCOSE URINE TEST STRIPS?

FIRST CHOICE GLUCOSE URINE TEST STRIPS is a medical device that received FDA 510(k) clearance on 1996-06-14. The listed applicant is Polymer Technology Intl.. The 510(k) number is K953661.

When did FIRST CHOICE GLUCOSE URINE TEST STRIPS receive FDA 510(k) clearance?

FIRST CHOICE GLUCOSE URINE TEST STRIPS received FDA 510(k) clearance on 1996-06-14, under 510(k) number K953661.

Who is the listed applicant for FIRST CHOICE GLUCOSE URINE TEST STRIPS?

The FDA 510(k) record lists Polymer Technology Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIRST CHOICE GLUCOSE URINE TEST STRIPS?

The FDA product code for FIRST CHOICE GLUCOSE URINE TEST STRIPS is JIL.

Related Clinical Trials

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Other records listing Polymer Technology Intl. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953672FIRST CHOICE URINARY TRACT INFECTION TEST STRIPSK953662FIRST CHOICE KETONES URINE TEST STRIPSK953680FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPSK950628FIRST CHOICE TEST STRIPK946166FIRST CHOICE(TM) TEST STRIP

Related Devices (Code: JIL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd.K180356inui In-Home Urine Analysis Test SystemScanadu, Inc.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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