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FDA 510(k)

LYSING & HEMOGLOBIN REAGENT

K-Number: K841800 · 1984-05-31

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

Device Summary

LYSING & HEMOGLOBIN 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 K841800. The device is classified under product code GGK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYSING & HEMOGLOBIN REAGENT?

LYSING & HEMOGLOBIN 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 K841800.

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

LYSING & HEMOGLOBIN REAGENT received FDA 510(k) clearance on 1984-05-31, under 510(k) number K841800.

Who is the listed applicant for LYSING & HEMOGLOBIN 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 LYSING & HEMOGLOBIN REAGENT?

The FDA product code for LYSING & HEMOGLOBIN REAGENT is GGK.

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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 BUFFEREDK842785STAIN, METHYLENE BLUE-EOSIN

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Related Devices (Code: GGK)

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.

K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter ImmunologyK883991KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTFisher Scientific Co., LLCK873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.Abbott DiagnosticsK863114PIASTRINITJ. D. Assoc.K863503HEMOLYSEReagent Laboratory, 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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