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FDA 510(k)

4C PLUS COULTER CELL CONTROL

K-Number: K955016 · 1996-01-30

ApplicantCoulter Corp.
Decision Date1996-01-30
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

4C PLUS COULTER CELL CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Corp.. It received FDA 510(k) clearance on 1996-01-30 under 510(k) number K955016. 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 4C PLUS COULTER CELL CONTROL?

4C PLUS COULTER CELL CONTROL is a medical device that received FDA 510(k) clearance on 1996-01-30. The listed applicant is Coulter Corp.. The 510(k) number is K955016.

When did 4C PLUS COULTER CELL CONTROL receive FDA 510(k) clearance?

4C PLUS COULTER CELL CONTROL received FDA 510(k) clearance on 1996-01-30, under 510(k) number K955016.

Who is the listed applicant for 4C PLUS COULTER CELL CONTROL?

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 4C PLUS COULTER CELL CONTROL?

The FDA product code for 4C PLUS COULTER CELL CONTROL 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

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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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