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FDA 510(k)

HEMOGLOBIN ANALYZER & PERFORM. CHECK SET

K-Number: K771101 · 1977-07-21

ApplicantThe Dow Chemical Co.
Decision Date1977-07-21
Product CodeGIG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN ANALYZER & PERFORM. CHECK SET is the device name listed in this FDA 510(k) record. The listed applicant is The Dow Chemical Co.. It received FDA 510(k) clearance on 1977-07-21 under 510(k) number K771101. The device is classified under product code GIG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOGLOBIN ANALYZER & PERFORM. CHECK SET?

HEMOGLOBIN ANALYZER & PERFORM. CHECK SET is a medical device that received FDA 510(k) clearance on 1977-07-21. The listed applicant is The Dow Chemical Co.. The 510(k) number is K771101.

When did HEMOGLOBIN ANALYZER & PERFORM. CHECK SET receive FDA 510(k) clearance?

HEMOGLOBIN ANALYZER & PERFORM. CHECK SET received FDA 510(k) clearance on 1977-07-21, under 510(k) number K771101.

Who is the listed applicant for HEMOGLOBIN ANALYZER & PERFORM. CHECK SET?

The FDA 510(k) record lists The Dow Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOGLOBIN ANALYZER & PERFORM. CHECK SET?

The FDA product code for HEMOGLOBIN ANALYZER & PERFORM. CHECK SET is GIG.

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Related Devices (Code: GIG)

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.

K973995RANDOX BILIRUBINRandox Laboratories, Ltd.K933836HBM HEMOGLOBINOMETERArtel, Inc.

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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