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FDA 510(k)

ROTAVIRUS ENZYME IMMUNOASSAY

K-Number: K843367 · 1985-06-13

ApplicantIntl. Diagnostic Laboratories, Ltd.
Decision Date1985-06-13
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROTAVIRUS ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Laboratories, Ltd.. It received FDA 510(k) clearance on 1985-06-13 under 510(k) number K843367. 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 ROTAVIRUS ENZYME IMMUNOASSAY?

ROTAVIRUS ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1985-06-13. The listed applicant is Intl. Diagnostic Laboratories, Ltd.. The 510(k) number is K843367.

When did ROTAVIRUS ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

ROTAVIRUS ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1985-06-13, under 510(k) number K843367.

Who is the listed applicant for ROTAVIRUS ENZYME IMMUNOASSAY?

The FDA 510(k) record lists Intl. Diagnostic Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROTAVIRUS ENZYME IMMUNOASSAY?

The FDA product code for ROTAVIRUS ENZYME IMMUNOASSAY is LIQ.

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 Intl. Diagnostic Laboratories, Ltd. 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.

K864811ROTA-STATK864228APO B., IMMUNOTURBIDIMETRIC ASSAYK864393APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC

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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