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FDA 510(k)

D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT

K-Number: K092882 · 2009-10-21

ApplicantDiagnostic Hybrids, Inc.
Decision Date2009-10-21
Product CodeGNW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Hybrids, Inc.. It received FDA 510(k) clearance on 2009-10-21 under 510(k) number K092882. 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 D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT?

D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT is a medical device that received FDA 510(k) clearance on 2009-10-21. The listed applicant is Diagnostic Hybrids, Inc.. The 510(k) number is K092882.

When did D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT receive FDA 510(k) clearance?

D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT received FDA 510(k) clearance on 2009-10-21, under 510(k) number K092882.

Who is the listed applicant for D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT?

The FDA 510(k) record lists Diagnostic Hybrids, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT?

The FDA product code for D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT is GNW.

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Other records listing Diagnostic Hybrids, Inc. 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.

K092229THYRETAIN TM TSI REPORTER BIOASSAYK093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITK093233D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KITK091171D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KITK091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMK092300MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT

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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.

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.K974302LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BLight Diagnostics

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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