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FDA 510(k)

COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE

K-Number: K070062 · 2007-07-30

ApplicantDiesse Diagnostica Senese S.P.A.
Decision Date2007-07-30
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE is the device name listed in this FDA 510(k) record. The listed applicant is Diesse Diagnostica Senese S.P.A.. It received FDA 510(k) clearance on 2007-07-30 under 510(k) number K070062. 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 COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE?

COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE is a medical device that received FDA 510(k) clearance on 2007-07-30. The listed applicant is Diesse Diagnostica Senese S.P.A.. The 510(k) number is K070062.

When did COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE receive FDA 510(k) clearance?

COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE received FDA 510(k) clearance on 2007-07-30, under 510(k) number K070062.

Who is the listed applicant for COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE?

The FDA 510(k) record lists Diesse Diagnostica Senese S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE?

The FDA product code for COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE 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.

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Other records listing Diesse Diagnostica Senese S.P.A. 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.

K050590ENZY-WELL SYPHILIS IGG, MODEL 91106

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.K013711BACTI-SWAB DRYRemel Co.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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