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FDA PMA

Fluorescence in situ hybridization, chromosome 17p deletion (TP53)

PMA Number: P150041 · 2026-02-18

ApplicantAbbott Molecular, Inc.
Decision Date2026-02-18
PMA NumberP150041
Product CodePNK
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

Fluorescence in situ hybridization, chromosome 17p deletion (TP53) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2026-02-18. The device is classified under product code PNK. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Fluorescence in situ hybridization, chromosome 17p deletion (TP53)?

Fluorescence in situ hybridization, chromosome 17p deletion (TP53) is a medical device that received FDA 510(k) clearance on 2026-02-18. The listed applicant is Abbott Molecular, Inc..

When did Fluorescence in situ hybridization, chromosome 17p deletion (TP53) receive FDA 510(k) clearance?

The clearance date for Fluorescence in situ hybridization, chromosome 17p deletion (TP53) can be found in the official FDA records.

Who is the listed applicant for Fluorescence in situ hybridization, chromosome 17p deletion (TP53)?

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

What is the FDA product code for Fluorescence in situ hybridization, chromosome 17p deletion (TP53)?

The FDA product code for Fluorescence in situ hybridization, chromosome 17p deletion (TP53) is PNK.

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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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