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FDA 510(k)

SNAP(R) ROTAVIRUS DIAGNOSTIC KIT

K-Number: K873565 · 1988-05-13

ApplicantMolecular Biosystems, Inc.
Decision Date1988-05-13
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SNAP(R) ROTAVIRUS DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Molecular Biosystems, Inc.. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K873565. 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 SNAP(R) ROTAVIRUS DIAGNOSTIC KIT?

SNAP(R) ROTAVIRUS DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Molecular Biosystems, Inc.. The 510(k) number is K873565.

When did SNAP(R) ROTAVIRUS DIAGNOSTIC KIT receive FDA 510(k) clearance?

SNAP(R) ROTAVIRUS DIAGNOSTIC KIT received FDA 510(k) clearance on 1988-05-13, under 510(k) number K873565.

Who is the listed applicant for SNAP(R) ROTAVIRUS DIAGNOSTIC KIT?

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

What is the FDA product code for SNAP(R) ROTAVIRUS DIAGNOSTIC KIT?

The FDA product code for SNAP(R) ROTAVIRUS DIAGNOSTIC KIT 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 Molecular Biosystems, 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.

K874544SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KITK873670SNAP CAMPYLOBACTOR DIAGNOSTIC KITK873932THE EXTRACTOR(TM)

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

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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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