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FDA 510(k)

FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS

K-Number: K961623 · 1996-06-07

ApplicantBecton Dickinson Monoclonal Center
Decision Date1996-06-07
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Monoclonal Center. It received FDA 510(k) clearance on 1996-06-07 under 510(k) number K961623. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS?

FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS is a medical device that received FDA 510(k) clearance on 1996-06-07. The listed applicant is Becton Dickinson Monoclonal Center. The 510(k) number is K961623.

When did FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS receive FDA 510(k) clearance?

FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS received FDA 510(k) clearance on 1996-06-07, under 510(k) number K961623.

Who is the listed applicant for FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS?

The FDA 510(k) record lists Becton Dickinson Monoclonal Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS?

The FDA product code for FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS is GKZ.

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Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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