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FDA 510(k)

SDI PREPAX DILUKIT M.

K-Number: K851320 · 1985-07-05

ApplicantScientific Distributors, Inc.
Decision Date1985-07-05
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SDI PREPAX DILUKIT M. 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 1985-07-05 under 510(k) number K851320. 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 M.?

SDI PREPAX DILUKIT M. is a medical device that received FDA 510(k) clearance on 1985-07-05. The listed applicant is Scientific Distributors, Inc.. The 510(k) number is K851320.

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

SDI PREPAX DILUKIT M. received FDA 510(k) clearance on 1985-07-05, under 510(k) number K851320.

Who is the listed applicant for SDI PREPAX DILUKIT M.?

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 M.?

The FDA product code for SDI PREPAX DILUKIT M. 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 KITK840044SDI PREPAX DILUKIT 29-1000K840041SDI PREPAX DILUKIT HWK840043SDI 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.

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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