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FDA 510(k)

SANDARE CYANMETHEMOGLOBIN REAGENT

K-Number: K792503 · 1979-12-31

ApplicantSandare Chemical Co., Inc.
Decision Date1979-12-31
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SANDARE CYANMETHEMOGLOBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Sandare Chemical Co., Inc.. It received FDA 510(k) clearance on 1979-12-31 under 510(k) number K792503. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDARE CYANMETHEMOGLOBIN REAGENT?

SANDARE CYANMETHEMOGLOBIN REAGENT is a medical device that received FDA 510(k) clearance on 1979-12-31. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K792503.

When did SANDARE CYANMETHEMOGLOBIN REAGENT receive FDA 510(k) clearance?

SANDARE CYANMETHEMOGLOBIN REAGENT received FDA 510(k) clearance on 1979-12-31, under 510(k) number K792503.

Who is the listed applicant for SANDARE CYANMETHEMOGLOBIN REAGENT?

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

What is the FDA product code for SANDARE CYANMETHEMOGLOBIN REAGENT?

The FDA product code for SANDARE CYANMETHEMOGLOBIN REAGENT is KHG.

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Other records listing Sandare Chemical Co., 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.

K872852EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TESTK862556SANDARE GLYCOHEMOGLOBIN PROCEDUREK860684SANDARE BCG ALBUMIN PROCEDUREK851395SANDARE IRON-BINDING CAPACITY PROCEDUREK851394SANDARE IRON PROCEDUREK844498SANDARE ALKALINE PHOSPHATASE PROCEDURE

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Related Devices (Code: KHG)

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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