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FDA 510(k)

ANA LATEX SLIDE TEST

K-Number: K800605 · 1980-04-02

ApplicantBiologics Intl., Inc.
Decision Date1980-04-02
Product CodeDHC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA LATEX SLIDE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Biologics Intl., Inc.. It received FDA 510(k) clearance on 1980-04-02 under 510(k) number K800605. 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 ANA LATEX SLIDE TEST?

ANA LATEX SLIDE TEST is a medical device that received FDA 510(k) clearance on 1980-04-02. The listed applicant is Biologics Intl., Inc.. The 510(k) number is K800605.

When did ANA LATEX SLIDE TEST receive FDA 510(k) clearance?

ANA LATEX SLIDE TEST received FDA 510(k) clearance on 1980-04-02, under 510(k) number K800605.

Who is the listed applicant for ANA LATEX SLIDE TEST?

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

What is the FDA product code for ANA LATEX SLIDE TEST?

The FDA product code for ANA LATEX SLIDE TEST is DHC.

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Other records listing Biologics Intl., 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.

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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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