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FDA 510(k)

PROFAST+ ASSAY

K-Number: K101855 · 2010-07-23

ApplicantGen-Probe Prodesse, Inc.
Decision Date2010-07-23
Product CodeOQW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROFAST+ ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe Prodesse, Inc.. It received FDA 510(k) clearance on 2010-07-23 under 510(k) number K101855. The device is classified under product code OQW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFAST+ ASSAY?

PROFAST+ ASSAY is a medical device that received FDA 510(k) clearance on 2010-07-23. The listed applicant is Gen-Probe Prodesse, Inc.. The 510(k) number is K101855.

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

PROFAST+ ASSAY received FDA 510(k) clearance on 2010-07-23, under 510(k) number K101855.

Who is the listed applicant for PROFAST+ ASSAY?

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

What is the FDA product code for PROFAST+ ASSAY?

The FDA product code for PROFAST+ ASSAY is OQW.

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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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Other records listing Gen-Probe 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.

K132238PROPARAFLU+ ASSAYK132237PRODESSE PROFAST+ ASSAYK132200PRO HMPV+ ASSAYK132159PROADENO+ ASSAYK132129PRODESSE PROFLU+ ASSAYK123274PROGASTRO SSCS ASSAY

View all 10 devices →

Related Devices (Code: OQW)

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.

K132237PRODESSE PROFAST+ ASSAYGen-Probe Prodesse, Inc.K130551CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and PreventionK123905CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and PreventionK120911XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)CepheidK111778JBAIDS INFLUENZA A SUBTYPING KITU.S Army Medical Materiel Development ActivityK111507CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and Prevention

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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