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FDA 510(k)

VARIANT II B-THALASSEMIA

K-Number: K991127 · 1999-06-10

ApplicantBio-Rad
Decision Date1999-06-10
Product CodeJPD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VARIANT II B-THALASSEMIA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1999-06-10 under 510(k) number K991127. 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 II B-THALASSEMIA?

VARIANT II B-THALASSEMIA is a medical device that received FDA 510(k) clearance on 1999-06-10. The listed applicant is Bio-Rad. The 510(k) number is K991127.

When did VARIANT II B-THALASSEMIA receive FDA 510(k) clearance?

VARIANT II B-THALASSEMIA received FDA 510(k) clearance on 1999-06-10, under 510(k) number K991127.

Who is the listed applicant for VARIANT II B-THALASSEMIA?

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 II B-THALASSEMIA?

The FDA product code for VARIANT II B-THALASSEMIA is JPD.

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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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.K924122VARIANT 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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