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FDA 510(k)

DETER. OF HEMOGLOBIN A2 USING THE DIAMAT

K-Number: K875102 · 1988-02-24

ApplicantBio-Rad
Decision Date1988-02-24
Product CodeJPD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DETER. OF HEMOGLOBIN A2 USING THE DIAMAT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1988-02-24 under 510(k) number K875102. 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 DETER. OF HEMOGLOBIN A2 USING THE DIAMAT?

DETER. OF HEMOGLOBIN A2 USING THE DIAMAT is a medical device that received FDA 510(k) clearance on 1988-02-24. The listed applicant is Bio-Rad. The 510(k) number is K875102.

When did DETER. OF HEMOGLOBIN A2 USING THE DIAMAT receive FDA 510(k) clearance?

DETER. OF HEMOGLOBIN A2 USING THE DIAMAT received FDA 510(k) clearance on 1988-02-24, under 510(k) number K875102.

Who is the listed applicant for DETER. OF HEMOGLOBIN A2 USING THE DIAMAT?

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 DETER. OF HEMOGLOBIN A2 USING THE DIAMAT?

The FDA product code for DETER. OF HEMOGLOBIN A2 USING THE DIAMAT is JPD.

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Other records listing Bio-Rad as applicant

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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-RadK924122VARIANT BETA-THALASSEMIA SHORT PROGRAMBio-RadK924496GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KITDrew Scientific , Ltd.K923318COLUMNMATE BETA-THAL HBA2 CONTROL - NORMALHelena LaboratoriesK923317COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMALHelena 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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