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FDA 510(k)

IDEIA(TM) ROTAVIRUS

K-Number: K932384 · 1993-12-27

ApplicantDako Diagnostics , Ltd.
Decision Date1993-12-27
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IDEIA(TM) ROTAVIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Dako Diagnostics , Ltd.. It received FDA 510(k) clearance on 1993-12-27 under 510(k) number K932384. 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 IDEIA(TM) ROTAVIRUS?

IDEIA(TM) ROTAVIRUS is a medical device that received FDA 510(k) clearance on 1993-12-27. The listed applicant is Dako Diagnostics , Ltd.. The 510(k) number is K932384.

When did IDEIA(TM) ROTAVIRUS receive FDA 510(k) clearance?

IDEIA(TM) ROTAVIRUS received FDA 510(k) clearance on 1993-12-27, under 510(k) number K932384.

Who is the listed applicant for IDEIA(TM) ROTAVIRUS?

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

What is the FDA product code for IDEIA(TM) ROTAVIRUS?

The FDA product code for IDEIA(TM) ROTAVIRUS 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 Dako Diagnostics , 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.

K981226IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3K973954IMAGEN RESPIRATORY SCREENK962037IMAGEN RESPIRATORY SCREENK940564IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATIONK943557IMAGEN

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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