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FDA 510(k)

PATHOLOGY INSTRUMENTATION & ACCESSORIES

K-Number: K823040 · 1983-01-14

ApplicantIris Remote Imaging Systems
Decision Date1983-01-14
Product CodeIBJ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

PATHOLOGY INSTRUMENTATION & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Iris Remote Imaging Systems. It received FDA 510(k) clearance on 1983-01-14 under 510(k) number K823040. 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 PATHOLOGY INSTRUMENTATION & ACCESSORIES?

PATHOLOGY INSTRUMENTATION & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Iris Remote Imaging Systems. The 510(k) number is K823040.

When did PATHOLOGY INSTRUMENTATION & ACCESSORIES receive FDA 510(k) clearance?

PATHOLOGY INSTRUMENTATION & ACCESSORIES received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823040.

Who is the listed applicant for PATHOLOGY INSTRUMENTATION & ACCESSORIES?

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

What is the FDA product code for PATHOLOGY INSTRUMENTATION & ACCESSORIES?

The FDA product code for PATHOLOGY INSTRUMENTATION & ACCESSORIES is IBJ.

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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.K874207THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATIONIntl. Remote Imaging SystemsK864049MCARTHUR MICROSCOPE, STANDARD METAL VERSIONPortable Medical Laboratories, Inc.K854735MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.Portable Medical Laboratories, Inc.K8222072XC 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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