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FDA 510(k)

RPS ADENO DETECTOR PLUS

K-Number: K110722 · 2011-05-17

ApplicantRapid Pathogen Screening, Inc.
Decision Date2011-05-17
Product CodeGOD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RPS ADENO DETECTOR PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Pathogen Screening, Inc.. It received FDA 510(k) clearance on 2011-05-17 under 510(k) number K110722. The device is classified under product code GOD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RPS ADENO DETECTOR PLUS?

RPS ADENO DETECTOR PLUS is a medical device that received FDA 510(k) clearance on 2011-05-17. The listed applicant is Rapid Pathogen Screening, Inc.. The 510(k) number is K110722.

When did RPS ADENO DETECTOR PLUS receive FDA 510(k) clearance?

RPS ADENO DETECTOR PLUS received FDA 510(k) clearance on 2011-05-17, under 510(k) number K110722.

Who is the listed applicant for RPS ADENO DETECTOR PLUS?

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

What is the FDA product code for RPS ADENO DETECTOR PLUS?

The FDA product code for RPS ADENO DETECTOR PLUS is GOD.

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 Rapid Pathogen Screening, 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.

K132066INFLAMMA DRY

Related Devices (Code: GOD)

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.

K052092RPS ADENO DETECTORRapid Pathogen ScreeningK990630SAS ADENO TESTSa Scientific, Inc.K972406ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEMImmunoprobe, Inc.K881894ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)Cambridge Bioscience Corp.K873312ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TESTCambridge Bioscience Corp.K873082ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TESTCambridge Bioscience 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.

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