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FDA 510(k)

RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L

K-Number: K011068 · 2002-04-11

ApplicantRhigene, Inc.
Decision Date2002-04-11
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L is the device name listed in this FDA 510(k) record. The listed applicant is Rhigene, Inc.. It received FDA 510(k) clearance on 2002-04-11 under 510(k) number K011068. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L?

RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L is a medical device that received FDA 510(k) clearance on 2002-04-11. The listed applicant is Rhigene, Inc.. The 510(k) number is K011068.

When did RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L receive FDA 510(k) clearance?

RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L received FDA 510(k) clearance on 2002-04-11, under 510(k) number K011068.

Who is the listed applicant for RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L?

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

What is the FDA product code for RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L?

The FDA product code for RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L is KTL.

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Related Devices (Code: KTL)

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.

K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus ScientificK203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemImmuno Concepts, N.A. , Ltd.K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc.K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEuroimmun Us, Inc.K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEuroimmun Us, Inc.K013432IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040GImmuno Concepts, Inc.

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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