FDA 510(k)

BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS

K-Number: K013203 · 2001-11-16

ApplicantPolymer Technology Systems, Inc.

Decision Date2001-11-16

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Systems, Inc.. It received FDA 510(k) clearance on 2001-11-16 under 510(k) number K013203. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS?

BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Polymer Technology Systems, Inc.. The 510(k) number is K013203.

When did BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS receive FDA 510(k) clearance?

BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS received FDA 510(k) clearance on 2001-11-16, under 510(k) number K013203.

Who is the listed applicant for BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS?

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

What is the FDA product code for BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS?

The FDA product code for BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS is NBW. This falls under the OB/GYN category.

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Official Source

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