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FDA 510(k)

THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION

K-Number: K874207 · 1988-01-05

ApplicantIntl. Remote Imaging Systems
Decision Date1988-01-05
Product CodeIBJ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Remote Imaging Systems. It received FDA 510(k) clearance on 1988-01-05 under 510(k) number K874207. The device is classified under product code IBJ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION?

THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION is a medical device that received FDA 510(k) clearance on 1988-01-05. The listed applicant is Intl. Remote Imaging Systems. The 510(k) number is K874207.

When did THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION receive FDA 510(k) clearance?

THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION received FDA 510(k) clearance on 1988-01-05, under 510(k) number K874207.

Who is the listed applicant for THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION?

The FDA 510(k) record lists Intl. Remote Imaging Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION?

The FDA product code for THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION is IBJ.

Related Clinical Trials

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.

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Other records listing Intl. Remote Imaging Systems 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.

K022774IQ 200 SYSTEMK000373939UDX URINE PATHOLOGY SYSTEMK972141THE YELLOW IRIS URINALYSIS WORKSTATIONK953116WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZERK960054900UDX URINE PATHOLOGY SYSTEMK954006YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY

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Related Devices (Code: IBJ)

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.

K874750VIDEO ANALYZER 4000Scientific Imaging, Inc.K874190CELL COUNTING GRID GRATICULEPortable Medical Laboratories, Inc.K864049MCARTHUR MICROSCOPE, STANDARD METAL VERSIONPortable Medical Laboratories, Inc.K854735MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.Portable Medical Laboratories, Inc.K823040PATHOLOGY INSTRUMENTATION & ACCESSORIESIris Remote Imaging SystemsK8222072XC MICROSCOPEAmarel Precision Instruments, 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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