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FDA 510(k)

VARIANT BETA-THALASSEMIA SHORT PROGRAM

K-Number: K924122 · 1993-03-11

ApplicantBio-Rad
Decision Date1993-03-11
Product CodeJPD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VARIANT BETA-THALASSEMIA SHORT PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1993-03-11 under 510(k) number K924122. 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 VARIANT BETA-THALASSEMIA SHORT PROGRAM?

VARIANT BETA-THALASSEMIA SHORT PROGRAM is a medical device that received FDA 510(k) clearance on 1993-03-11. The listed applicant is Bio-Rad. The 510(k) number is K924122.

When did VARIANT BETA-THALASSEMIA SHORT PROGRAM receive FDA 510(k) clearance?

VARIANT BETA-THALASSEMIA SHORT PROGRAM received FDA 510(k) clearance on 1993-03-11, under 510(k) number K924122.

Who is the listed applicant for VARIANT BETA-THALASSEMIA SHORT PROGRAM?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIANT BETA-THALASSEMIA SHORT PROGRAM?

The FDA product code for VARIANT BETA-THALASSEMIA SHORT PROGRAM 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.

K020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODETosoh Medics, Inc.K991127VARIANT II B-THALASSEMIABio-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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