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FDA 510(k)

IS-DSDNA TEST SYSTEM

K-Number: K974694 · 1998-03-03

ApplicantDiamedix Corp.
Decision Date1998-03-03
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IS-DSDNA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1998-03-03 under 510(k) number K974694. 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 IS-DSDNA TEST SYSTEM?

IS-DSDNA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-03. The listed applicant is Diamedix Corp.. The 510(k) number is K974694.

When did IS-DSDNA TEST SYSTEM receive FDA 510(k) clearance?

IS-DSDNA TEST SYSTEM received FDA 510(k) clearance on 1998-03-03, under 510(k) number K974694.

Who is the listed applicant for IS-DSDNA TEST SYSTEM?

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

What is the FDA product code for IS-DSDNA TEST SYSTEM?

The FDA product code for IS-DSDNA TEST SYSTEM is LRM.

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Other records listing Diamedix Corp. 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.

K093101MAGO 4SK021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

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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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