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FDA 510(k)

IMAGEN RESPIRATORY SCREEN

K-Number: K973954 · 1997-12-22

ApplicantDako Diagnostics , Ltd.
Decision Date1997-12-22
Product CodeGNW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMAGEN RESPIRATORY SCREEN 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 1997-12-22 under 510(k) number K973954. The device is classified under product code GNW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGEN RESPIRATORY SCREEN?

IMAGEN RESPIRATORY SCREEN is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Dako Diagnostics , Ltd.. The 510(k) number is K973954.

When did IMAGEN RESPIRATORY SCREEN receive FDA 510(k) clearance?

IMAGEN RESPIRATORY SCREEN received FDA 510(k) clearance on 1997-12-22, under 510(k) number K973954.

Who is the listed applicant for IMAGEN RESPIRATORY SCREEN?

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 IMAGEN RESPIRATORY SCREEN?

The FDA product code for IMAGEN RESPIRATORY SCREEN is GNW.

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 3K962037IMAGEN RESPIRATORY SCREENK940564IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATIONK943557IMAGENK932384IDEIA(TM) ROTAVIRUS

Related Devices (Code: GNW)

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.

K092882D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.K092300MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.K081746D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.K061101D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.K022713DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.K003204BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KITIntracel Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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