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FDA 510(k)

BT3/6, BT12

K-Number: K082077 · 2008-09-02

ApplicantCorscience GmbH & Co. KG
Decision Date2008-09-02
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BT3/6, BT12 is the device name listed in this FDA 510(k) record. The listed applicant is Corscience GmbH & Co. KG. It received FDA 510(k) clearance on 2008-09-02 under 510(k) number K082077. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BT3/6, BT12?

BT3/6, BT12 is a medical device that received FDA 510(k) clearance on 2008-09-02. The listed applicant is Corscience GmbH & Co. KG. The 510(k) number is K082077.

When did BT3/6, BT12 receive FDA 510(k) clearance?

BT3/6, BT12 received FDA 510(k) clearance on 2008-09-02, under 510(k) number K082077.

Who is the listed applicant for BT3/6, BT12?

The FDA 510(k) record lists Corscience GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BT3/6, BT12?

The FDA product code for BT3/6, BT12 is DXH. This falls under the Hematology category.

Other records listing Corscience GmbH & Co. KG 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.

K193159NeuroAmp II, NeuroAmp II.5sK112077HBIDB - HUMAN BRIAN INDEX SOFTWAREK073557EEG NEUROAMP, MODEL CS10137

Related Devices (Code: DXH)

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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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