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

FDA 510(k)

PRO HMPV+ ASSAY

K-Number: K082688 · 2008-11-07

ApplicantProdesse, Inc.
Decision Date2008-11-07
Product CodeOEM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PRO HMPV+ ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Prodesse, Inc.. It received FDA 510(k) clearance on 2008-11-07 under 510(k) number K082688. The device is classified under product code OEM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO HMPV+ ASSAY?

PRO HMPV+ ASSAY is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Prodesse, Inc.. The 510(k) number is K082688.

When did PRO HMPV+ ASSAY receive FDA 510(k) clearance?

PRO HMPV+ ASSAY received FDA 510(k) clearance on 2008-11-07, under 510(k) number K082688.

Who is the listed applicant for PRO HMPV+ ASSAY?

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

What is the FDA product code for PRO HMPV+ ASSAY?

The FDA product code for PRO HMPV+ ASSAY is OEM.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Prodesse, Inc. 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.

K091053PROPARAFLU+ASSAYK092500MODIFICATION TO PROFLU+ ASSAYK090239PROGASTRO CD ASSAYK081030MODIFICATION TO PROFLU+ ASSAYK073029PROFLU+ ASSAY

Related Devices (Code: OEM)

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.

K230349Lyra RSV+hMPV AssayQuidel CorporationK132200PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.K122189QUIDEL MOLECULAR RSV + HMPV ASSAYQuidel Corp.K123838PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.K112490QUIDEL MOLECULAR HMPV ASSAYQuidel 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.

↑