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FDA 510(k)

AUTOSTATTMII ANTI-DSDNA

K-Number: K952567 · 1997-03-04

ApplicantCogent Diagnotics , Ltd.
Decision Date1997-03-04
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTATTMII ANTI-DSDNA is the device name listed in this FDA 510(k) record. The listed applicant is Cogent Diagnotics , Ltd.. It received FDA 510(k) clearance on 1997-03-04 under 510(k) number K952567. The device is classified under product code LRM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOSTATTMII ANTI-DSDNA?

AUTOSTATTMII ANTI-DSDNA is a medical device that received FDA 510(k) clearance on 1997-03-04. The listed applicant is Cogent Diagnotics , Ltd.. The 510(k) number is K952567.

When did AUTOSTATTMII ANTI-DSDNA receive FDA 510(k) clearance?

AUTOSTATTMII ANTI-DSDNA received FDA 510(k) clearance on 1997-03-04, under 510(k) number K952567.

Who is the listed applicant for AUTOSTATTMII ANTI-DSDNA?

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

What is the FDA product code for AUTOSTATTMII ANTI-DSDNA?

The FDA product code for AUTOSTATTMII ANTI-DSDNA is LRM.

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Other records listing Cogent Diagnotics , Ltd. 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: LRM)

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.

K101319IMMULISA DSDNA ANTIBODY ELISAImmco Diagnostics, Inc.K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)Euroimmun Us, Inc.K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.K040811VARELISA SSDNA ANTIBODIES, MODEL 14896Pharmacia Deutschland GmbHK001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTHelix Diagnostics, Inc.K000477MDI DS-DNA TESTMicro Detect, 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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