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FDA 510(k)

KARYOTEC 100

K-Number: K872755 · 1987-09-01

ApplicantAmcor Electronics, Ltd.
Decision Date1987-09-01
Product CodeLNJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KARYOTEC 100 is the device name listed in this FDA 510(k) record. The listed applicant is Amcor Electronics, Ltd.. It received FDA 510(k) clearance on 1987-09-01 under 510(k) number K872755. 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 KARYOTEC 100?

KARYOTEC 100 is a medical device that received FDA 510(k) clearance on 1987-09-01. The listed applicant is Amcor Electronics, Ltd.. The 510(k) number is K872755.

When did KARYOTEC 100 receive FDA 510(k) clearance?

KARYOTEC 100 received FDA 510(k) clearance on 1987-09-01, under 510(k) number K872755.

Who is the listed applicant for KARYOTEC 100?

The FDA 510(k) record lists Amcor Electronics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARYOTEC 100?

The FDA product code for KARYOTEC 100 is LNJ.

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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-TechnologyK902311GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.Applied Imaging Corp.K895095AKS IIAmoco Technology Co.

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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