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)

ROTACLONE ROTAVIRUS DIAGNOSTIC KIT

K-Number: K852969 · 1985-11-05

ApplicantCambridge Bioscience Corp.
Decision Date1985-11-05
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROTACLONE ROTAVIRUS DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Bioscience Corp.. It received FDA 510(k) clearance on 1985-11-05 under 510(k) number K852969. 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 ROTACLONE ROTAVIRUS DIAGNOSTIC KIT?

ROTACLONE ROTAVIRUS DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1985-11-05. The listed applicant is Cambridge Bioscience Corp.. The 510(k) number is K852969.

When did ROTACLONE ROTAVIRUS DIAGNOSTIC KIT receive FDA 510(k) clearance?

ROTACLONE ROTAVIRUS DIAGNOSTIC KIT received FDA 510(k) clearance on 1985-11-05, under 510(k) number K852969.

Who is the listed applicant for ROTACLONE ROTAVIRUS DIAGNOSTIC KIT?

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

What is the FDA product code for ROTACLONE ROTAVIRUS DIAGNOSTIC KIT?

The FDA product code for ROTACLONE ROTAVIRUS DIAGNOSTIC 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 Cambridge Bioscience Corp. 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.

K890281HUMAN LYME EIA FOR THE DETECT OF ANTIBODIESK881894ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)K873312ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TESTK873082ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST

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.

↑