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FDA 510(k)

CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127

K-Number: K092868 · 2009-11-20

ApplicantCellaVision AB
Decision Date2009-11-20
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 is the device name listed in this FDA 510(k) record. The listed applicant is CellaVision AB. It received FDA 510(k) clearance on 2009-11-20 under 510(k) number K092868. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127?

CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 is a medical device that received FDA 510(k) clearance on 2009-11-20. The listed applicant is CellaVision AB. The 510(k) number is K092868.

When did CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 receive FDA 510(k) clearance?

CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 received FDA 510(k) clearance on 2009-11-20, under 510(k) number K092868.

Who is the listed applicant for CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127?

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

What is the FDA product code for CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127?

The FDA product code for CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 is JOY.

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Other records listing CellaVision AB 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.

K200595CellaVision DC-1, CellaVision DC-1 PPAK171315Advanced RBC ApplicationK102778CELLAVISION DM1200 WITH THE BODY FLUID APPLICTIONK080595CELLAVISION DM96 WITH THE BODY FLUID APPLICATIONK033840CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZERK003301DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

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Related Devices (Code: JOY)

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.

K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K221309AI100 with ShonitSigtuple Technologies Pvt. , Ltd.K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision ABK201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceSysmex America, Inc.

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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