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FDA 510(k)

IDL-LYSING REAGENT

K-Number: K842069 · 1984-07-02

ApplicantInterscience Diagnostics, Inc.
Decision Date1984-07-02
Product CodeGGK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IDL-LYSING REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Interscience Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-07-02 under 510(k) number K842069. 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 IDL-LYSING REAGENT?

IDL-LYSING REAGENT is a medical device that received FDA 510(k) clearance on 1984-07-02. The listed applicant is Interscience Diagnostics, Inc.. The 510(k) number is K842069.

When did IDL-LYSING REAGENT receive FDA 510(k) clearance?

IDL-LYSING REAGENT received FDA 510(k) clearance on 1984-07-02, under 510(k) number K842069.

Who is the listed applicant for IDL-LYSING REAGENT?

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

What is the FDA product code for IDL-LYSING REAGENT?

The FDA product code for IDL-LYSING REAGENT is GGK.

Related Clinical Trials

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Other records listing Interscience Diagnostics, 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.

K854166HEMATOLOGY CALIBRATOR CONTROLK842070IDD DETERGENTK842068IDI ISOTONIC DILUENT

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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