FDA 510(k)

NSI LYSING-D REAGENT -4000 ML

K-Number: K850944 · 1985-03-29

ApplicantNobel Scientific Industries, Inc.

Decision Date1985-03-29

Product CodeGGK

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

NSI LYSING-D REAGENT -4000 ML is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Scientific Industries, Inc.. It received FDA 510(k) clearance on 1985-03-29 under 510(k) number K850944. 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 NSI LYSING-D REAGENT -4000 ML?

NSI LYSING-D REAGENT -4000 ML is a medical device that received FDA 510(k) clearance on 1985-03-29. The listed applicant is Nobel Scientific Industries, Inc.. The 510(k) number is K850944.

When did NSI LYSING-D REAGENT -4000 ML receive FDA 510(k) clearance?

NSI LYSING-D REAGENT -4000 ML received FDA 510(k) clearance on 1985-03-29, under 510(k) number K850944.

Who is the listed applicant for NSI LYSING-D REAGENT -4000 ML?

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

What is the FDA product code for NSI LYSING-D REAGENT -4000 ML?

The FDA product code for NSI LYSING-D REAGENT -4000 ML is GGK.

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Other records listing Nobel Scientific Industries, Inc. as applicant

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Related Devices (Code: GGK)

K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter Immunology K883991KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTFisher Scientific Co., LLC K873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.Abbott Diagnostics K863114PIASTRINITJ. 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.