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FDA 510(k)

COULTER FLOW SET

K-Number: K944751 · 1994-12-08

ApplicantCoulter Corp.
Decision Date1994-12-08
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER FLOW SET is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Corp.. It received FDA 510(k) clearance on 1994-12-08 under 510(k) number K944751. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER FLOW SET?

COULTER FLOW SET is a medical device that received FDA 510(k) clearance on 1994-12-08. The listed applicant is Coulter Corp.. The 510(k) number is K944751.

When did COULTER FLOW SET receive FDA 510(k) clearance?

COULTER FLOW SET received FDA 510(k) clearance on 1994-12-08, under 510(k) number K944751.

Who is the listed applicant for COULTER FLOW SET?

The FDA 510(k) record lists Coulter Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COULTER FLOW SET?

The FDA product code for COULTER FLOW SET is JPK.

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Other records listing Coulter Corp. 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.

K993356COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSESK991070COULTER Z2 ANALYZERK990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSK990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLAK990352COULTER AC T DIFF 2 ANALYZERK984216IMMUNO-TROL CONTROL CELLS

View all 51 devices →

Related Devices (Code: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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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