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FDA 510(k)

HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)

K-Number: K011389 · 2001-06-21

ApplicantCanterbury Health Laboratories
Decision Date2001-06-21
Product CodeJCM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) is the device name listed in this FDA 510(k) record. The listed applicant is Canterbury Health Laboratories. It received FDA 510(k) clearance on 2001-06-21 under 510(k) number K011389. 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 HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)?

HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) is a medical device that received FDA 510(k) clearance on 2001-06-21. The listed applicant is Canterbury Health Laboratories. The 510(k) number is K011389.

When did HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) receive FDA 510(k) clearance?

HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) received FDA 510(k) clearance on 2001-06-21, under 510(k) number K011389.

Who is the listed applicant for HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)?

The FDA 510(k) record lists Canterbury Health Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)?

The FDA product code for HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA 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.

K053031EXTENDSURE HBFASC CONTROLCantebury Scientific , Ltd.K983704MODIFICATION 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

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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