Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Panther Fusion GI Bacterial Assay

K-Number: K251868 · 2025-09-25

ApplicantHologic
Decision Date2025-09-25
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Panther Fusion GI Bacterial Assay is a medical device manufactured by Hologic. It received FDA 510(k) clearance on 2025-09-25 under approval number K251868. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panther Fusion GI Bacterial Assay?

Panther Fusion GI Bacterial Assay is a medical device that received FDA 510(k) clearance on 2025-09-25. It is manufactured by Hologic. The 510(k) number is K251868.

When was Panther Fusion GI Bacterial Assay approved by the FDA?

Panther Fusion GI Bacterial Assay received FDA 510(k) clearance on 2025-09-25, under approval number K251868.

What company makes Panther Fusion GI Bacterial Assay?

Panther Fusion GI Bacterial Assay is manufactured by Hologic.

What is the FDA product code for Panther Fusion GI Bacterial Assay?

The FDA product code for Panther Fusion GI Bacterial Assay is PCH.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT02107989 Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05810259 Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life RECRUITING NCT07614945 Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia NOT_YET_RECRUITING NCT07611643 Bruxism Therapy of Facial Pain RECRUITING

Related PubMed Literature

PMID: 42119715 Integrated chemical and molecular authentication of Pinellia tuber: A multinational collaboration within the FHH ATLAS project with government regulatory agencies from seven countries and regions. Fitoterapia (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40890852 Study protocol for a prospective, randomized controlled confirmatory clinical investigation to evaluate the safety and efficacy of a multidisciplinary digital therapeutics in patients with patellofemoral pain syndrome. Trials (2025) PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

Other Devices by Hologic

K161575Affirm Lateral Arm Upright Biopsy Accessory

Related Devices (Code: PCH)

K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC K152955Great Basin Shiga Toxin Direct TestGreat Basin Scientific, Inc. K170308BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc. K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc. K181427BD MAX Enteric Viral Panel, BD MAX InstrumentBecton, Dickinson and Company

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.

↑