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FDA 510(k)

CARESIDE APTT

K-Number: K014028 · 2002-02-08

ApplicantCareside Hemotology, Inc.
Decision Date2002-02-08
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CARESIDE APTT is the device name listed in this FDA 510(k) record. The listed applicant is Careside Hemotology, Inc.. It received FDA 510(k) clearance on 2002-02-08 under 510(k) number K014028. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESIDE APTT?

CARESIDE APTT is a medical device that received FDA 510(k) clearance on 2002-02-08. The listed applicant is Careside Hemotology, Inc.. The 510(k) number is K014028.

When did CARESIDE APTT receive FDA 510(k) clearance?

CARESIDE APTT received FDA 510(k) clearance on 2002-02-08, under 510(k) number K014028.

Who is the listed applicant for CARESIDE APTT?

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

What is the FDA product code for CARESIDE APTT?

The FDA product code for CARESIDE APTT is GFO.

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Related Devices (Code: GFO)

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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