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FDA 510(k)

ANTI-DS/N-DNA TEST KIT

K-Number: K801960 · 1980-10-10

ApplicantImmuno-Diagnostic Products, Inc.
Decision Date1980-10-10
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-DS/N-DNA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Diagnostic Products, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K801960. 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-DS/N-DNA TEST KIT?

ANTI-DS/N-DNA TEST KIT is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Immuno-Diagnostic Products, Inc.. The 510(k) number is K801960.

When did ANTI-DS/N-DNA TEST KIT receive FDA 510(k) clearance?

ANTI-DS/N-DNA TEST KIT received FDA 510(k) clearance on 1980-10-10, under 510(k) number K801960.

Who is the listed applicant for ANTI-DS/N-DNA TEST KIT?

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

What is the FDA product code for ANTI-DS/N-DNA TEST KIT?

The FDA product code for ANTI-DS/N-DNA TEST KIT is DBL.

Other records listing Immuno-Diagnostic Products, 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.

K854207EBV(EPSTEIN-BARR VIRUS) TEST KITK811021HERPESK811562TOXOPLASMOSIS TEST KITK811022ANA TEST KITK801959FTA-ABS TESTK801963CMV TEST KIT

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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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