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FDA PMA

ENZYME IMMUNOASSAY, FETAL FIBRONECTIN

PMA Number: P920048 · 2026-08-26

ApplicantHologic, Inc.
Decision Date2026-08-26
PMA NumberP920048
Product CodeLKV
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeTX

Device Summary

ENZYME IMMUNOASSAY, FETAL FIBRONECTIN is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2026-08-26. The device is classified under product code LKV. It was reviewed by the TX advisory panel.

Frequently Asked Questions

What is the ENZYME IMMUNOASSAY, FETAL FIBRONECTIN?

ENZYME IMMUNOASSAY, FETAL FIBRONECTIN is a medical device that received FDA 510(k) clearance on 2026-08-26. The listed applicant is Hologic, Inc..

When did ENZYME IMMUNOASSAY, FETAL FIBRONECTIN receive FDA 510(k) clearance?

The clearance date for ENZYME IMMUNOASSAY, FETAL FIBRONECTIN can be found in the official FDA records.

Who is the listed applicant for ENZYME IMMUNOASSAY, FETAL FIBRONECTIN?

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

What is the FDA product code for ENZYME IMMUNOASSAY, FETAL FIBRONECTIN?

The FDA product code for ENZYME IMMUNOASSAY, FETAL FIBRONECTIN is LKV.

Related Clinical Trials

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.

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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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