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FDA 510(k)

IDI ISOTONIC DILUENT

K-Number: K842068 · 1984-07-02

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

Device Summary

IDI ISOTONIC DILUENT 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 K842068. 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 IDI ISOTONIC DILUENT?

IDI ISOTONIC DILUENT 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 K842068.

When did IDI ISOTONIC DILUENT receive FDA 510(k) clearance?

IDI ISOTONIC DILUENT received FDA 510(k) clearance on 1984-07-02, under 510(k) number K842068.

Who is the listed applicant for IDI ISOTONIC DILUENT?

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 IDI ISOTONIC DILUENT?

The FDA product code for IDI ISOTONIC DILUENT is GIF.

Related Clinical Trials

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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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 DETERGENTK842069IDL-LYSING REAGENT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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