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FDA 510(k)

BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT

K-Number: K003204 · 2000-11-07

ApplicantIntracel Corp.
Decision Date2000-11-07
Product CodeGNW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intracel Corp.. It received FDA 510(k) clearance on 2000-11-07 under 510(k) number K003204. 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 BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT?

BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT is a medical device that received FDA 510(k) clearance on 2000-11-07. The listed applicant is Intracel Corp.. The 510(k) number is K003204.

When did BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT receive FDA 510(k) clearance?

BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT received FDA 510(k) clearance on 2000-11-07, under 510(k) number K003204.

Who is the listed applicant for BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT?

The FDA 510(k) record lists Intracel Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT?

The FDA product code for BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT 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.

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Other records listing Intracel Corp. 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.

K991074BARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTK990664PRIMA SYSTEM - OLD, BARTELS ELISA - NEWK982311BARTELS CINAKIT CMV ANTIGENEMIAK933878ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT

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.K974302LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BLight Diagnostics

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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