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FDA 510(k)

ABP-2000 G-3

K-Number: K021029 · 2002-04-12

ApplicantBiotrac, Inc.
Decision Date2002-04-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ABP-2000 G-3 is the device name listed in this FDA 510(k) record. The listed applicant is Biotrac, Inc.. It received FDA 510(k) clearance on 2002-04-12 under 510(k) number K021029. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABP-2000 G-3?

ABP-2000 G-3 is a medical device that received FDA 510(k) clearance on 2002-04-12. The listed applicant is Biotrac, Inc.. The 510(k) number is K021029.

When did ABP-2000 G-3 receive FDA 510(k) clearance?

ABP-2000 G-3 received FDA 510(k) clearance on 2002-04-12, under 510(k) number K021029.

Who is the listed applicant for ABP-2000 G-3?

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

What is the FDA product code for ABP-2000 G-3?

The FDA product code for ABP-2000 G-3 is DXN.

Related Devices (Code: DXN)

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.

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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.

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