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FDA 510(k)

IMAGEN

K-Number: K943557 · 1995-01-09

ApplicantDako Diagnostics , Ltd.
Decision Date1995-01-09
Product CodeGQS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMAGEN 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 1995-01-09 under 510(k) number K943557. The device is classified under product code GQS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGEN?

IMAGEN is a medical device that received FDA 510(k) clearance on 1995-01-09. The listed applicant is Dako Diagnostics , Ltd.. The 510(k) number is K943557.

When did IMAGEN receive FDA 510(k) clearance?

IMAGEN received FDA 510(k) clearance on 1995-01-09, under 510(k) number K943557.

Who is the listed applicant for IMAGEN?

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?

The FDA product code for IMAGEN is GQS.

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.

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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, MODIFICATIONK932384IDEIA(TM) ROTAVIRUS

Related Devices (Code: GQS)

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.

K093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.K905385P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGENVirion (U.S.), Inc.K884193PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECTBaxter Diagnostics, Inc.K884194PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECTBaxter Diagnostics, Inc.K871234ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1Microscan Div. Baxter Healthcare Corp.K871232ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3Microscan Div. Baxter Healthcare Corp.

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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