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FDA 510(k)

BIOSCANNER 2000

K-Number: K013068 · 2001-11-20

ApplicantPolymer Technology Systems, Inc.
Decision Date2001-11-20
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSCANNER 2000 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 2001-11-20 under 510(k) number K013068. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSCANNER 2000?

BIOSCANNER 2000 is a medical device that received FDA 510(k) clearance on 2001-11-20. The listed applicant is Polymer Technology Systems, Inc.. The 510(k) number is K013068.

When did BIOSCANNER 2000 receive FDA 510(k) clearance?

BIOSCANNER 2000 received FDA 510(k) clearance on 2001-11-20, under 510(k) number K013068.

Who is the listed applicant for BIOSCANNER 2000?

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 2000?

The FDA product code for BIOSCANNER 2000 is CGA.

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Related Devices (Code: CGA)

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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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