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FDA 510(k)

GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.

K-Number: K902311 · 1990-08-20

ApplicantApplied Imaging Corp.
Decision Date1990-08-20
Product CodeLNJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. is the device name listed in this FDA 510(k) record. The listed applicant is Applied Imaging Corp.. It received FDA 510(k) clearance on 1990-08-20 under 510(k) number K902311. The device is classified under product code LNJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.?

GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. is a medical device that received FDA 510(k) clearance on 1990-08-20. The listed applicant is Applied Imaging Corp.. The 510(k) number is K902311.

When did GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. receive FDA 510(k) clearance?

GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. received FDA 510(k) clearance on 1990-08-20, under 510(k) number K902311.

Who is the listed applicant for GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.?

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

What is the FDA product code for GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.?

The FDA product code for GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. is LNJ.

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Other records listing Applied Imaging Corp. 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.

K043519ARIOL HER-2/NEU FISHK042542CYTOVISION FOR CEP XYK033200ARIOLK031715ARIOL HER-2/NEU IHCK001420SLIDESCANK980375WINSCAN AUTOMATED IMAGING SYSTEM

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Related Devices (Code: LNJ)

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.

K050236FISHVIEWApplied Spectral Imaging , Ltd.K012103BANDVIEW SYSTEMApplied Spectral Imaging , Ltd.K940240IKAROSMetasystems GmbHK912085ACLAIMS-ISW-TechnologyK895095AKS IIAmoco Technology Co.K872755KARYOTEC 100Amcor Electronics, Ltd.

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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