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FDA 510(k)

ARIOL HER-2/NEU FISH

K-Number: K043519 · 2005-04-25

ApplicantApplied Imaging Corp.
Decision Date2005-04-25
Product CodeNTH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ARIOL HER-2/NEU FISH 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 2005-04-25 under 510(k) number K043519. The device is classified under product code NTH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIOL HER-2/NEU FISH?

ARIOL HER-2/NEU FISH is a medical device that received FDA 510(k) clearance on 2005-04-25. The listed applicant is Applied Imaging Corp.. The 510(k) number is K043519.

When did ARIOL HER-2/NEU FISH receive FDA 510(k) clearance?

ARIOL HER-2/NEU FISH received FDA 510(k) clearance on 2005-04-25, under 510(k) number K043519.

Who is the listed applicant for ARIOL HER-2/NEU FISH?

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 ARIOL HER-2/NEU FISH?

The FDA product code for ARIOL HER-2/NEU FISH is NTH.

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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.

K042542CYTOVISION FOR CEP XYK033200ARIOLK031715ARIOL HER-2/NEU IHCK001420SLIDESCANK980375WINSCAN AUTOMATED IMAGING SYSTEMK902311GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.

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Related Devices (Code: NTH)

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.

K122554GENASIS SCANVIEW SYSTEMApplied Spectral Imaging , Ltd.K110345SCANVIEW SYSTEMApplied Spectral ImagingK101291SCANVIEW HER2/NEU FISH SYSTEMApplied Spectral Imaging , Ltd.K080909ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000Ikonisys, Inc.K042542CYTOVISION FOR CEP XYApplied Imaging Corp.

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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