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FDA 510(k)

IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3

K-Number: K981226 · 1998-09-28

ApplicantDako Diagnostics , Ltd.
Decision Date1998-09-28
Product CodeGQP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 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 1998-09-28 under 510(k) number K981226. The device is classified under product code GQP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3?

IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 is a medical device that received FDA 510(k) clearance on 1998-09-28. The listed applicant is Dako Diagnostics , Ltd.. The 510(k) number is K981226.

When did IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 receive FDA 510(k) clearance?

IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 received FDA 510(k) clearance on 1998-09-28, under 510(k) number K981226.

Who is the listed applicant for IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3?

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 IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3?

The FDA product code for IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 is GQP.

Related Clinical Trials

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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.

K973954IMAGEN RESPIRATORY SCREENK962037IMAGEN RESPIRATORY SCREENK940564IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATIONK943557IMAGENK932384IDEIA(TM) ROTAVIRUS

Related Devices (Code: GQP)

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.

K933575VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANTSymex 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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