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FDA 510(k)

HBM HEMOGLOBINOMETER

K-Number: K933836 · 1994-03-31

ApplicantArtel, Inc.
Decision Date1994-03-31
Product CodeGIG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HBM HEMOGLOBINOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Artel, Inc.. It received FDA 510(k) clearance on 1994-03-31 under 510(k) number K933836. 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 HBM HEMOGLOBINOMETER?

HBM HEMOGLOBINOMETER is a medical device that received FDA 510(k) clearance on 1994-03-31. The listed applicant is Artel, Inc.. The 510(k) number is K933836.

When did HBM HEMOGLOBINOMETER receive FDA 510(k) clearance?

HBM HEMOGLOBINOMETER received FDA 510(k) clearance on 1994-03-31, under 510(k) number K933836.

Who is the listed applicant for HBM HEMOGLOBINOMETER?

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

What is the FDA product code for HBM HEMOGLOBINOMETER?

The FDA product code for HBM HEMOGLOBINOMETER is GIG.

Related Clinical Trials

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Other records listing Artel, 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.

K920914MP/S SINGLE WAVELENGTH MINI PHOTOMETERK914809MP MINI PHOTOMETERK864542ARTEL DIFFERENTIAL PHOTOMETER

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.K771101HEMOGLOBIN ANALYZER & PERFORM. CHECK SETThe Dow Chemical Co.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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