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FDA 510(k)

CYANOMETHEMOGLOBIN REAGENT

K-Number: K841799 · 1984-05-31

ApplicantReagent Laboratory, Inc.
Decision Date1984-05-31
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CYANOMETHEMOGLOBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Reagent Laboratory, Inc.. It received FDA 510(k) clearance on 1984-05-31 under 510(k) number K841799. The device is classified under product code GIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYANOMETHEMOGLOBIN REAGENT?

CYANOMETHEMOGLOBIN REAGENT is a medical device that received FDA 510(k) clearance on 1984-05-31. The listed applicant is Reagent Laboratory, Inc.. The 510(k) number is K841799.

When did CYANOMETHEMOGLOBIN REAGENT receive FDA 510(k) clearance?

CYANOMETHEMOGLOBIN REAGENT received FDA 510(k) clearance on 1984-05-31, under 510(k) number K841799.

Who is the listed applicant for CYANOMETHEMOGLOBIN REAGENT?

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

What is the FDA product code for CYANOMETHEMOGLOBIN REAGENT?

The FDA product code for CYANOMETHEMOGLOBIN REAGENT is GIF.

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Other records listing Reagent Laboratory, 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.

K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/LK863503HEMOLYSEK863550POTASSIUM HYDROXIDE 10% W/VK860143URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODEK842982FORMALIN BUFFEREDK843050GRAM STAIN

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Related Devices (Code: GIF)

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.

K883990KVM ISOTONIC DILUENTKvm Technologies, Inc.K883989KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.K882490HYCEL QUICK-LYSING HEMOGLOBIN REAGENTR&D Systems, Inc.K882267SYSMEX QUICKLYSER-II (QLS-200A)Toa Medical Electronics USA, Inc.K881130CELL-DYN ISOTONIC DILUENTAbbott DiagnosticsK873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott Diagnostics

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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