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FDA 510(k)

ANTI NDNA IMMUNOFLOURESCENT TEST SYS

K-Number: K810981 · 1981-04-29

ApplicantImmuno-Products Industries
Decision Date1981-04-29
Product CodeDHC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI NDNA IMMUNOFLOURESCENT TEST SYS is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Products Industries. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K810981. The device is classified under product code DHC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI NDNA IMMUNOFLOURESCENT TEST SYS?

ANTI NDNA IMMUNOFLOURESCENT TEST SYS is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Immuno-Products Industries. The 510(k) number is K810981.

When did ANTI NDNA IMMUNOFLOURESCENT TEST SYS receive FDA 510(k) clearance?

ANTI NDNA IMMUNOFLOURESCENT TEST SYS received FDA 510(k) clearance on 1981-04-29, under 510(k) number K810981.

Who is the listed applicant for ANTI NDNA IMMUNOFLOURESCENT TEST SYS?

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

What is the FDA product code for ANTI NDNA IMMUNOFLOURESCENT TEST SYS?

The FDA product code for ANTI NDNA IMMUNOFLOURESCENT TEST SYS is DHC.

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Other records listing Immuno-Products Industries 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.

K853122IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPEDK852230ANA/LITE-RL TEST SYSTEMK852231ANA/LITE-HEP-2 TEST SYSTEMK843613FLUORESCENT TREPONEMEL ANTIBODY-ABSORBK831054ANTINUCLEAR ANTIBODY TISSUE CULTURE SUBK830652ANTI N DNA-HCP

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Related Devices (Code: DHC)

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.

K001352REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITCorgenix, Inc.K001398REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITCorgenix, Inc.K930421ELIAS DSDNA ABSElias U.S.A., Inc.K930247HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USEThe Binding Site, Ltd.K914801IMMUNOWELL DSDNA ANTIBODY TESTGeneral Biometrics, Inc.K885048ACCESS R-CLONE ANA PROFILE ASSAYLipogen, 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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