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FDA 510(k)

SLIDEX ROTA-KIT 2

K-Number: K895805 · 1991-02-26

ApplicantVitek Systems, Inc.
Decision Date1991-02-26
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SLIDEX ROTA-KIT 2 is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1991-02-26 under 510(k) number K895805. The device is classified under product code LIQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLIDEX ROTA-KIT 2?

SLIDEX ROTA-KIT 2 is a medical device that received FDA 510(k) clearance on 1991-02-26. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K895805.

When did SLIDEX ROTA-KIT 2 receive FDA 510(k) clearance?

SLIDEX ROTA-KIT 2 received FDA 510(k) clearance on 1991-02-26, under 510(k) number K895805.

Who is the listed applicant for SLIDEX ROTA-KIT 2?

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

What is the FDA product code for SLIDEX ROTA-KIT 2?

The FDA product code for SLIDEX ROTA-KIT 2 is LIQ.

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Other records listing Vitek Systems, Inc. as applicant

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K920661VIDAS CMV IGG ASSAYK921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYK915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONK905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

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Related Devices (Code: LIQ)

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.

K990842SAS ROTA TESTSa Scientific, Inc.K972895VIDAS ROTAVIRUS (RTV) ASSAYBiomerieux Vitek, Inc.K971585IMMUNOCARD STAT! ROTAVIRUSMeridian Diagnostics, Inc.K964424ROTAVIRUS EIATrinity Biotech, Inc.K965092VIDAS ROTAVIRUS ASSAYBiomerieux Vitek, Inc.K951208ROTA-DAN RAPID ROTAVIRUS EIA KITEldan Technologies, Ltd.

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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