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FDA 510(k)

G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE

K-Number: K020489 · 2002-05-14

ApplicantTosoh Medics, Inc.
Decision Date2002-05-14
Product CodeJPD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Medics, Inc.. It received FDA 510(k) clearance on 2002-05-14 under 510(k) number K020489. The device is classified under product code JPD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE?

G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE is a medical device that received FDA 510(k) clearance on 2002-05-14. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K020489.

When did G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE receive FDA 510(k) clearance?

G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE received FDA 510(k) clearance on 2002-05-14, under 510(k) number K020489.

Who is the listed applicant for G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE?

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

What is the FDA product code for G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE?

The FDA product code for G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE is JPD.

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Related Devices (Code: JPD)

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.

K991127VARIANT II B-THALASSEMIABio-RadK924122VARIANT BETA-THALASSEMIA SHORT PROGRAMBio-RadK924496GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KITDrew Scientific , Ltd.K923317COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMALHelena LaboratoriesK923318COLUMNMATE BETA-THAL HBA2 CONTROL - NORMALHelena LaboratoriesK913384COLUMNMATE(TM) BETA-THAL CAT. NO. 4515Helena Laboratories

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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