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FDA 510(k)

DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

K-Number: K003301 · 2001-03-15

ApplicantCellaVision AB
Decision Date2001-03-15
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is CellaVision AB. It received FDA 510(k) clearance on 2001-03-15 under 510(k) number K003301. 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 DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER?

DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 2001-03-15. The listed applicant is CellaVision AB. The 510(k) number is K003301.

When did DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER received FDA 510(k) clearance on 2001-03-15, under 510(k) number K003301.

Who is the listed applicant for DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER?

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 DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER?

The FDA product code for DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER 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 APPLICTIONK092868CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127K080595CELLAVISION DM96 WITH THE BODY FLUID APPLICATIONK033840CELLAVISION DM96 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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