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FDA 510(k)

SDI PREPAX DILUKIT HW

K-Number: K840041 · 1984-03-05

ApplicantScientific Distributors, Inc.
Decision Date1984-03-05
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SDI PREPAX DILUKIT HW 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 1984-03-05 under 510(k) number K840041. 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 SDI PREPAX DILUKIT HW?

SDI PREPAX DILUKIT HW is a medical device that received FDA 510(k) clearance on 1984-03-05. The listed applicant is Scientific Distributors, Inc.. The 510(k) number is K840041.

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

SDI PREPAX DILUKIT HW received FDA 510(k) clearance on 1984-03-05, under 510(k) number K840041.

Who is the listed applicant for SDI PREPAX DILUKIT HW?

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 SDI PREPAX DILUKIT HW?

The FDA product code for SDI PREPAX DILUKIT HW 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 29-1000K840043SDI PREPAX DILUKIT CTK840038PREPAX DILUKIT PLUSK840042SDI 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.

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

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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