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 LATEX AGGLUTINATION ASSAY

K-Number: K861172 · 1986-07-01

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1986-07-01
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROTAVIRUS LATEX AGGLUTINATION ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1986-07-01 under 510(k) number K861172. 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 LATEX AGGLUTINATION ASSAY?

ROTAVIRUS LATEX AGGLUTINATION ASSAY is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K861172.

When did ROTAVIRUS LATEX AGGLUTINATION ASSAY receive FDA 510(k) clearance?

ROTAVIRUS LATEX AGGLUTINATION ASSAY received FDA 510(k) clearance on 1986-07-01, under 510(k) number K861172.

Who is the listed applicant for ROTAVIRUS LATEX AGGLUTINATION ASSAY?

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

What is the FDA product code for ROTAVIRUS LATEX AGGLUTINATION ASSAY?

The FDA product code for ROTAVIRUS LATEX AGGLUTINATION ASSAY 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 Bartels Immunodiagnostic Supplies, 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.

K864776A549 (HUMAN LUNG CARCINOMA) CULTURE CELLSK860279CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KITK855034AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANTK842830IMMUNOPER-OXIDASE TEST KIT FOR DETECT OFK852185RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANTK844105FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY

View all 35 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.

↑