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FDA 510(k)

ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER

K-Number: K944192 · 1995-03-06

ApplicantLight Diagnostics
Decision Date1995-03-06
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER is the device name listed in this FDA 510(k) record. The listed applicant is Light Diagnostics. It received FDA 510(k) clearance on 1995-03-06 under 510(k) number K944192. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER?

ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is Light Diagnostics. The 510(k) number is K944192.

When did ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER receive FDA 510(k) clearance?

ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER received FDA 510(k) clearance on 1995-03-06, under 510(k) number K944192.

Who is the listed applicant for ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER?

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

What is the FDA product code for ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER?

The FDA product code for ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER is DBL.

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Other records listing Light Diagnostics 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.

K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYK990141LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295K972975LIGHT DIAGNOSTICS RABIES DFA REAGENTK974302LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BK951821CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

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Related Devices (Code: DBL)

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.

K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K980312NOVA LITE ENDOMYSIALInova Diagnostics, Inc.K974169WIELISA ANTI-GBM TEST SYSTEMWieslab ABK971464IMMUNOSCAN ANTI-GBM QUANTITATIVE KITEuro-Diagnostica ABK971658MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KITJay H. GellerK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITShield Diagnostics, Ltd.

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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