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FDA 510(k)

BACTI-SWAB(TM) II

K-Number: K912831 · 1991-07-30

ApplicantRemel Co.
Decision Date1991-07-30
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTI-SWAB(TM) II is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1991-07-30 under 510(k) number K912831. 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(TM) II?

BACTI-SWAB(TM) II is a medical device that received FDA 510(k) clearance on 1991-07-30. The listed applicant is Remel Co.. The 510(k) number is K912831.

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

BACTI-SWAB(TM) II received FDA 510(k) clearance on 1991-07-30, under 510(k) number K912831.

Who is the listed applicant for BACTI-SWAB(TM) II?

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(TM) II?

The FDA product code for BACTI-SWAB(TM) II is LIO.

Related Clinical Trials

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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.

K013711BACTI-SWAB DRYK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

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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.

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