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FDA 510(k)

PREPAX DILUKIT PLUS

K-Number: K840038 · 1984-02-10

ApplicantScientific Distributors, Inc.
Decision Date1984-02-10
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PREPAX DILUKIT PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Distributors, Inc.. It received FDA 510(k) clearance on 1984-02-10 under 510(k) number K840038. 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 PREPAX DILUKIT PLUS?

PREPAX DILUKIT PLUS is a medical device that received FDA 510(k) clearance on 1984-02-10. The listed applicant is Scientific Distributors, Inc.. The 510(k) number is K840038.

When did PREPAX DILUKIT PLUS receive FDA 510(k) clearance?

PREPAX DILUKIT PLUS received FDA 510(k) clearance on 1984-02-10, under 510(k) number K840038.

Who is the listed applicant for PREPAX DILUKIT PLUS?

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

What is the FDA product code for PREPAX DILUKIT PLUS?

The FDA product code for PREPAX DILUKIT PLUS is GIF.

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Other records listing Scientific Distributors, 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.

K892658SDI PREPAX COUNTAPETTE KITK851320SDI PREPAX DILUKIT M.K840044SDI PREPAX DILUKIT 29-1000K840041SDI PREPAX DILUKIT HWK840043SDI PREPAX DILUKIT CTK840042SDI PREPAX DILUKIT CA

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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.

K883989KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.K883990KVM ISOTONIC DILUENTKvm 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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