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FDA 510(k)

METACHROME

K-Number: K851174 · 1985-05-23

ApplicantPotomac Medical System
Decision Date1985-05-23
Product CodeLNJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

METACHROME is the device name listed in this FDA 510(k) record. The listed applicant is Potomac Medical System. It received FDA 510(k) clearance on 1985-05-23 under 510(k) number K851174. 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 METACHROME?

METACHROME is a medical device that received FDA 510(k) clearance on 1985-05-23. The listed applicant is Potomac Medical System. The 510(k) number is K851174.

When did METACHROME receive FDA 510(k) clearance?

METACHROME received FDA 510(k) clearance on 1985-05-23, under 510(k) number K851174.

Who is the listed applicant for METACHROME?

The FDA 510(k) record lists Potomac Medical System as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METACHROME?

The FDA product code for METACHROME is LNJ.

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Other records listing Potomac Medical System 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.

K790637COMPUTERIZED ELECTRO-OCULOGRAPH

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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