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FDA 510(k)

HEMOGLOBIN REAGENT SET

K-Number: K841057 · 1984-03-23

ApplicantMedical Specialties, Inc.
Decision Date1984-03-23
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K841057. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOGLOBIN REAGENT SET?

HEMOGLOBIN REAGENT SET is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Medical Specialties, Inc.. The 510(k) number is K841057.

When did HEMOGLOBIN REAGENT SET receive FDA 510(k) clearance?

HEMOGLOBIN REAGENT SET received FDA 510(k) clearance on 1984-03-23, under 510(k) number K841057.

Who is the listed applicant for HEMOGLOBIN REAGENT SET?

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

What is the FDA product code for HEMOGLOBIN REAGENT SET?

The FDA product code for HEMOGLOBIN REAGENT SET is GKR.

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Other records listing Medical Specialties, 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.

K946201STAND, INFUSIONK931947CHECKPOINTK926095REFRACTROL-SPK924926MSI-HCTK896566MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVEK883851MSI-CAL 8

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Related Devices (Code: GKR)

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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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