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FDA 510(k)

HEMOGLOBIN A2 MICRO COLUMN TEST

K-Number: K896168 · 1990-01-18

ApplicantBio-Rad
Decision Date1990-01-18
Product CodeJPD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN A2 MICRO COLUMN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1990-01-18 under 510(k) number K896168. 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 HEMOGLOBIN A2 MICRO COLUMN TEST?

HEMOGLOBIN A2 MICRO COLUMN TEST is a medical device that received FDA 510(k) clearance on 1990-01-18. The listed applicant is Bio-Rad. The 510(k) number is K896168.

When did HEMOGLOBIN A2 MICRO COLUMN TEST receive FDA 510(k) clearance?

HEMOGLOBIN A2 MICRO COLUMN TEST received FDA 510(k) clearance on 1990-01-18, under 510(k) number K896168.

Who is the listed applicant for HEMOGLOBIN A2 MICRO COLUMN TEST?

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 HEMOGLOBIN A2 MICRO COLUMN TEST?

The FDA product code for HEMOGLOBIN A2 MICRO COLUMN TEST 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.

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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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