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)

ROTAVIRUS BIO-ENZABEAD SCREEN KIT

K-Number: K834443 · 1984-03-16

ApplicantLitton Bionetics
Decision Date1984-03-16
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROTAVIRUS BIO-ENZABEAD SCREEN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Litton Bionetics. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K834443. 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 BIO-ENZABEAD SCREEN KIT?

ROTAVIRUS BIO-ENZABEAD SCREEN KIT is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Litton Bionetics. The 510(k) number is K834443.

When did ROTAVIRUS BIO-ENZABEAD SCREEN KIT receive FDA 510(k) clearance?

ROTAVIRUS BIO-ENZABEAD SCREEN KIT received FDA 510(k) clearance on 1984-03-16, under 510(k) number K834443.

Who is the listed applicant for ROTAVIRUS BIO-ENZABEAD SCREEN KIT?

The FDA 510(k) record lists Litton Bionetics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROTAVIRUS BIO-ENZABEAD SCREEN KIT?

The FDA product code for ROTAVIRUS BIO-ENZABEAD SCREEN KIT 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Litton Bionetics 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.

K840417EBNA ACIF KITK831343CMV RQ BIO-ENZABEAD KITK822985EBV-M KITK821804RUBELLA RQ BIO-ENZABEAD KITK801722CMV BIO-BEAD TITRATION KITK801721HSV BIO-BEAD TITRATION KIT

View all 15 devices →

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.

↑