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)

BACTI-SWAB DRY

K-Number: K013711 · 2001-11-26

ApplicantRemel Co.
Decision Date2001-11-26
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTI-SWAB DRY is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 2001-11-26 under 510(k) number K013711. 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 BACTI-SWAB DRY?

BACTI-SWAB DRY is a medical device that received FDA 510(k) clearance on 2001-11-26. The listed applicant is Remel Co.. The 510(k) number is K013711.

When did BACTI-SWAB DRY receive FDA 510(k) clearance?

BACTI-SWAB DRY received FDA 510(k) clearance on 2001-11-26, under 510(k) number K013711.

Who is the listed applicant for BACTI-SWAB DRY?

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

What is the FDA product code for BACTI-SWAB DRY?

The FDA product code for BACTI-SWAB DRY 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 Remel Co. 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.

K965149A.C.T. IK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK960090CALCOFLUOR WHITE STAIN KITK960095BACTIDROP CALCOFLUOR WHITE

View all 137 devices →

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.K131630PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEMPuritan Medical Products, LLCK120846TRANSPORT 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.

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.

↑