Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ROTA-STAT

K-Number: K864811 · 1987-08-25

ApplicantIntl. Diagnostic Laboratories, Ltd.
Decision Date1987-08-25
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROTA-STAT 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 1987-08-25 under 510(k) number K864811. 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 ROTA-STAT?

ROTA-STAT is a medical device that received FDA 510(k) clearance on 1987-08-25. The listed applicant is Intl. Diagnostic Laboratories, Ltd.. The 510(k) number is K864811.

When did ROTA-STAT receive FDA 510(k) clearance?

ROTA-STAT received FDA 510(k) clearance on 1987-08-25, under 510(k) number K864811.

Who is the listed applicant for ROTA-STAT?

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 ROTA-STAT?

The FDA product code for ROTA-STAT is LIQ.

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.

K864228APO B., IMMUNOTURBIDIMETRIC ASSAYK864393APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRICK843367ROTAVIRUS ENZYME IMMUNOASSAY

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.

↑