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FDA 510(k)

HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12

K-Number: K874429 · 1988-02-04

ApplicantHf Scientific, Inc.
Decision Date1988-02-04
Product CodeGIQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 is the device name listed in this FDA 510(k) record. The listed applicant is Hf Scientific, Inc.. It received FDA 510(k) clearance on 1988-02-04 under 510(k) number K874429. The device is classified under product code GIQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12?

HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 is a medical device that received FDA 510(k) clearance on 1988-02-04. The listed applicant is Hf Scientific, Inc.. The 510(k) number is K874429.

When did HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 receive FDA 510(k) clearance?

HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 received FDA 510(k) clearance on 1988-02-04, under 510(k) number K874429.

Who is the listed applicant for HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12?

The FDA 510(k) record lists Hf Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12?

The FDA product code for HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 is GIQ.

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Other records listing Hf Scientific, Inc. 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.

K882801RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.K880967MICRO CO2 APPARATUSK864313CO2 REAGENT SETK864862REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.

Related Devices (Code: GIQ)

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.

K955719SICKLE-2000Medicus Technologies, Inc.K942276QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAYIsolab, 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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