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FDA 510(k)

2XC MICROSCOPE

K-Number: K822207 · 1982-08-05

ApplicantAmarel Precision Instruments, Inc.
Decision Date1982-08-05
Product CodeIBJ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

2XC MICROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Amarel Precision Instruments, Inc.. It received FDA 510(k) clearance on 1982-08-05 under 510(k) number K822207. 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 2XC MICROSCOPE?

2XC MICROSCOPE is a medical device that received FDA 510(k) clearance on 1982-08-05. The listed applicant is Amarel Precision Instruments, Inc.. The 510(k) number is K822207.

When did 2XC MICROSCOPE receive FDA 510(k) clearance?

2XC MICROSCOPE received FDA 510(k) clearance on 1982-08-05, under 510(k) number K822207.

Who is the listed applicant for 2XC MICROSCOPE?

The FDA 510(k) record lists Amarel Precision Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2XC MICROSCOPE?

The FDA product code for 2XC MICROSCOPE 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.K823040PATHOLOGY INSTRUMENTATION & ACCESSORIESIris Remote Imaging Systems

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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