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FDA 510(k)

EXTENDSURE HBFASC CONTROL

K-Number: K053031 · 2005-12-07

ApplicantCantebury Scientific , Ltd.
Decision Date2005-12-07
Product CodeJCM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EXTENDSURE HBFASC CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Cantebury Scientific , Ltd.. It received FDA 510(k) clearance on 2005-12-07 under 510(k) number K053031. The device is classified under product code JCM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTENDSURE HBFASC CONTROL?

EXTENDSURE HBFASC CONTROL is a medical device that received FDA 510(k) clearance on 2005-12-07. The listed applicant is Cantebury Scientific , Ltd.. The 510(k) number is K053031.

When did EXTENDSURE HBFASC CONTROL receive FDA 510(k) clearance?

EXTENDSURE HBFASC CONTROL received FDA 510(k) clearance on 2005-12-07, under 510(k) number K053031.

Who is the listed applicant for EXTENDSURE HBFASC CONTROL?

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

What is the FDA product code for EXTENDSURE HBFASC CONTROL?

The FDA product code for EXTENDSURE HBFASC CONTROL is JCM.

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Related Devices (Code: JCM)

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.

K011389HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)Canterbury Health LaboratoriesK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINERoche Diagnostic Systems, Inc.K942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLSIsolab, Inc.K933086AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328Helena LaboratoriesK931234HEMOCARD CONTROL HB-AA, AE, FAA, FAEIsolab, Inc.K924173HEMOCARD(TM) CONTROLIsolab, Inc.

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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