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)

PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM

K-Number: K131630 · 2013-10-21

ApplicantPuritan Medical Products, LLC
Decision Date2013-10-21
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Medical Products, LLC. It received FDA 510(k) clearance on 2013-10-21 under 510(k) number K131630. The device is classified under product code LIO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM?

PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-21. The listed applicant is Puritan Medical Products, LLC. The 510(k) number is K131630.

When did PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM receive FDA 510(k) clearance?

PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM received FDA 510(k) clearance on 2013-10-21, under 510(k) number K131630.

Who is the listed applicant for PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM?

The FDA 510(k) record lists Puritan Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM?

The FDA product code for PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM is LIO.

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 Puritan Medical Products, LLC 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.

K242820Puritan PurSafe Plus Collection and Transport SystemK162284Puritan Fecal Opti-Swab Collection and Transport SystemK160082Puritan Opti-Tranz Cary-Blair Collection and Transport SystemK120846TRANSPORT CULTURE MEDIUM DEVICEK113249TRANSPORT CULTURE MEDIUM DEVICE

Related Devices (Code: LIO)

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.

K222613ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc.K120846TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLCK103805MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICEMedical Wire & Equipment Company (Bath), Ltd.K082472VIROCULT, MODEL MW950Medical Wire & Equipment Company (Bath), Ltd.K070062COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USEDiesse Diagnostica Senese S.P.A.K013711BACTI-SWAB DRYRemel Co.

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.

↑